Brampton, ON – In the ever-evolving world of medical and dental imaging, portable handheld X-ray devices have emerged as a game-changer. They offer numerous advantages over traditional wall-mounted X-ray machines and are becoming increasingly popular in both the dental and veterinary fields.

Handheld X-Ray Wall Mounted X-Ray
  • No Installation
  • Portable
  • Cordless
  • Remaining in the room allows you to control patient’s movement and skillfully take pictures at any desired position due to its mobility (less retakes needed)
  • Less radiation per exposure
  • Only one unit needed per clinic
  • Mounting Block Needed
  • Stationary
  • Power Source needed Close By
  • Limited control on how to angle and take pictures. The wall mount can sway causing blurry images
  • Higher tube current leads to greater exposure of radiation for the same clarity of images
  • Limited to one unit per operatory

Safety

One of the primary concerns when it comes to X-ray technology is safety. Portable handheld X-ray devices are designed with operator and patient safety in mind.

  1. Reduced Radiation Exposure: Handheld X-ray devices typically emit significantly lower levels of radiation compared to traditional machines, which is a big win for both operators and patients. The reduced exposure minimizes health risks associated with radiation.
  2. Operator Protection: Operators can maintain a safe distance from the X-ray source during exposure, further reducing their radiation exposure. Additionally, these devices often come with radiation shielding and lead aprons for added protection.
  3. Patient Comfort: The portability of handheld X-rays allows for more patient-friendly positioning, making the process less intimidating. This results in a more comfortable experience and may even reduce the need for sedation in some cases.

The ALARA Principle

ALARA stands for “As Low As Reasonably Achievable” and is a guiding principle in radiation safety. Portable handheld X-ray devices align with the ALARA principle by minimizing radiation exposure while maintaining diagnostic quality. This principle emphasizes the importance of reducing radiation to the lowest possible levels while maintaining the necessary diagnostic information.

USA Regulations and Approvals

STATE Approved Additional Requirements
Alabama Approved • Owner Needs handheld exemption form
Alaska Approved • No restrictions as long as unit is FDA approved
Arizona Approved • No bystanders within 6 ft and can’t be used in hallways/waiting rooms
Arkansas Approved • Length of cone or spacer, 18 cm above 50 kVp (X-Vision has a collimator cone and spacer of 20cm)
California Approved • The portable x-ray system must have FDA approval and is being used in a manner consistent with that approval.
• The backscatter shield provided by the manufacturer, of not less than 0.25 mm lead equivalent, must be permanently affixed in place at all times. (X-Vision has 0.35 mm lead equivalent backscatter shield)
• Personnel monitoring badges must be worn by all individuals operating the portable devices. Monitoring results must be evaluated internally on a monthly basis.
• All personnel must receive training in the safe use of the x-ray systems.
• All training and monitoring records must be made available for review by CDPH-RHB upon request.
Colorado Approved • Must bear a label indicating it meets FDA standards.
Connecticut Approved • The physical layout that will allow an operator to stand at least six feet from the source of ionizing radiation or behind a protective barrier during x-ray exposures. (X-Vision comes with a 10ft remote activator and optional stand for purchase)
• Measurement to ensure that kVp accuracy is within plus or minus 10% of the selected kVp.
Delaware Approved • Owner needs to apply for variance at Delaware Radiology Board
Florida Approved • Dosimetry Badge Needed
Georgia Approved • Unit must be used with dosimetry badge, lead apron, and have a permanently affixed backscatter shield
Hawaii Approved • Warning label (“Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.”
• Source-to-skin distance (SSD) shall not be less than eighteen centimeters (SSD on X-Visio it is 20cm)
Idaho Approved The following label is required to be affixed to the approved device:
• “Designed and manufactured in compliance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-2-7, and DHHS Rules 21 CFR Subchapter J, applicable at date of manufacture.
• Label must also include “This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed.”
Illinois Approved • No restrictions as long as unit is FDA approved
Indiana Approved • Owner of Handheld dental machines must apply for an exemption request to the Indiana rule for radiation control, 410 IAC 5.
**The exemption request should state the reason(s) you are purchasing a hand held device (i.e. sedated patients, space limitations, etc.) mentioning the unit is approved by FDA.  Also, please note the manufacturer/model.  Noting the dentist that will be responsible for the unit(s) and that same individual will need to sign the exemption request.In addition, please note how operators will be trained by manufacturer
Iowa Approved • No requirements as long as it is FDA approved
Kansas Approved • A waiver must be applied for
Kentucky Approved • No requirements as long as it is FDA approved
Louisiana Approved  • Ask for an exemption to LAC 33:XV.607.A.3.e and 607.A.8.b
•  Cannot HOLD X-Ray (X-Vision comes with remote activator)
• 12ft away or a 6.5ft high barrier during exposure
Maine Approved • Dosimetry Badge Required
1) The inspection of the unit is required within one year by a Maine Qualified Expert.
2) Unit shall only be used where a shielding design has been completed and required shielding has
been installed. Using the dental x-ray systems in the field (not in a shielded room) will require a
written procedure approved in advance by the Radiation Control Program.
3) The registrant shall comply with all regulations regarding dose limits to, and monitoring of,
personnel including, but not limited to, Part D Sections 1201, 1301 and 1502.
4) Unit shall only be used at the facility where it is registered. Unit may not be loaned out to a facility
not registered to use it.
5) Repeat Rates: Tracking repeat rates is an important aspect of Quality Assurance and is required
for users of hand held systems as well as stationary systems. While this data does not need to be
sent to our office it must be available in the event an onsite inspection by Maine Radiation Control
Program personnel is warranted.
6) Part D. Sections 1801 and 1802 (Storage and Control of Licensed or Registered Sources of
Radiation) will apply to this unit to guard against the potential for unauthorized use of hand held units.
7) All persons using hand held or portable units in the field will be required to submit safety and operational procedures to the Radiation Control Program for prior approval.
Maryland Approved • Registration is Required by RHP
• Must have Fixed Wall Mounted X-Ray as well
Massachusetts Approved •  Lead Apron
• Training Required
Michigan NOT Approved • 0.5mm Lead Back Scatter required  (X-Vision has only 0.35 mm)
Minnesota Approved • Lead Apron Must be Worn
Mississippi Approved •  12 feet from Tube Head for Activation
•  Tripod or Stand Required
Missouri Approved • No restrictions as long as unit is FDA approved
Montana Approved • 6ft away to activate
•  Lead Apron Must be Worn• Tripod or Stand Required
Nebraska Approved • Tripod or Stand Required
Nevada Approved •  Training Certificate Required
• Lead Apron Required with Thyroid Collar
•  Dosimetry Badge Required by Operator
New Hampshire Approved •  2m high barrier
•  9ft way from tube head during exposure (X-Vision has 10 ft remote activator)• Tripod or Stand Required
New Jersey Approved • Device registered with NJ Radiation Department
New Mexico Approved • Training for use Required
•  Exemption Application Required by Facility
New York Approved  •Device is registered and application has been submitted by manufacturer
North Carolina Approved •  Must be used with Tripod
•  Must be used with a Fixed Cord for Exposure Activation
•  Dosimetry Badge Must be Worn
•  Manufacturer must provide training and certificate
•  Written Radiation Safety Program be submitted
North Dakota Approved • No restrictions as long as unit is FDA approved
Ohio Approved • Hand-held dental radiation-generating equipment is permitted in Ohio. As long as your dental hand-held radiation-generating equipment is FDA approved, it should meet all the dental equipment requirements.
Oklahoma Approved • No restrictions as long as unit is FDA approved
Oregon Approved • Device Registered with Oregon State Department
Pennsylvania Approved • All hand-held X-ray units that have been certified by the manufacturer to meet the FDA’s radiation safety standards must bear a certification label/tag, a warning label, and an identification (ID) label/tag on the unit’s housing.
•  All labels/tags should be in the English language and permanently affixed or inscribed on each product so that they are legible and readily accessible when the X-ray unit is fully assembled for use. Refer to FDA’s 21 CFR 1010.2
Rhode Island Approved • No restrictions as long as unit is FDA approved
South Carolina Approved • User Submits a Letter for Exception to Bureau of Radiological Health- Division of Electronic Products
South Dakota  Approved • No restrictions as long as unit is FDA approved
Tennessee Approved • No restrictions as long as unit is FDA approved
Texas Approved • X-ray units must be registered by an EPE certified technician
Utah Not Approved • Lead equivalent of the shield at the end of the cone must be at least 0.5mm
Vermont Approved • Unit has been registered and approved by State of Vermont
Virginia Approved • As long as your unit is FDA approved, you are permitted to sell the hand held dental unit in Virginia.

•The buyer must have the unit registered and inspected by a state or approved private inspector.

•Dosimetry is not required; however the user must wear a lead apron.
Washington Approved • Variance required to be submitted
• Apron Required
West Virginia Approved • No restrictions as long as unit is FDA approved
Wisconsin Approved with conditions A dental radiographic unit that is designed to be operated as a hand− held unit shall meet all the following requirements: (a) For all uses:
1. Operators of hand−held intraoral dental radiographic units shall be trained to operate such equipment. The training shall cover: manufacturer specific exposure control, use of safety devices, operator and patient protection, and quality control testing.
2. When operating a hand−held intraoral dental radiographic unit, operators shall wear a lead apron and thyroid collar unless the hand−held intraoral device has a secondary protective barrier.
3. A hand−held intraoral dental radiographic unit shall be immobilized during a patient examination. A tube stand may be utilized to immobilize a hand−held intraoral dental radiographic unit during patient examination.
4. The operator shall ensure there are no bystanders within a radius of at least 2 meters (6.5 ft) from the patient being examined during exposures.
(b) For permanent facilities:
1. Hand−held intraoral dental radiographic units shall be used for patient examinations in dental offices that meet the structural shielding requirements specified by the department.
2. Hand−held intraoral dental radiographic units may not be used for patient examinations in hallways and waiting rooms
Wyoming Approved • No restrictions as long as unit is FDA approved

CANADIAN – Regulations

Province Regulations
British Columbia Approved for Sale
– Register with Province for use of device
– Annual Inspection Required
Alberta Approved for Sale
– Register with Province for use of device
– Annual Inspection Required
– Tripod or Stand Required with Remote Activation for General Dentist Office
Saskatchewan Approved for Sale
– Register with Province for use of device
– Annual Inspection Required

– Needs Approval from Radiation Safety – Special Circumstances only

– Tripod or Stand Required with Remote Activation for General Dentist Office
Manitoba Approved for Sale
– Register with Province for use of device
– Annual Inspection Required

– Needs Approval from Radiation Protection Services – Special Circumstances only

– Tripod or Stand Required with Remote Activation for General Dentist Office
Ontario Approved for Sale
– Register with Province for use of device
– Annual Inspection Required
– Tripod or Stand Required with Remote Activation for General Dentist Office
Quebec Approved for Sale
– Only in Long Term Care Facilities
PEI Approved for Sale
– Register with Province for use of device
– Annual Inspection Required
New Brunswick Approved for Sale
– Register with Province for use of device
– Annual Inspection Required
Nova Scotia Approved for Sale
– Register with Province for use of device
– Annual Inspection Required

Comparison Chart

Flight Dental System’s

X-Vision – XR-3800

 Vector Maxray KaVo Nomad Pro 2 Vatech EzRay Air GenoRay

Port-X  IV

 Digital Doc XTG Midmark Preva
Tube Voltage 60 kV 65 kV 60 kV 65 kV 70 kV 60 kV 60-70 kV
Tube Current 2.0 mA 1.7 mA 2.5 mA 2.5 mA 2.0 mA 2.0 mA 4-7 mA
Exposure Time Range 0.02-2.0 s 0.05-1.35 s 0.02-1.0 s 0.05-1.0 s 0.5 s 0.01-1.0 s 0.01-2.0 s
Battery Life (Exposures) 2900 mAh

(800 exposures)

 1050 mAh

(300-500 exposures)

 2400mAh

(600 exposures)

 2500 mAh

(400 exposures)

 1000 mAh

(300 exposures)

 1000 mAh

(350 expsures)

 N/A
Weight 6.6 lbs 6 lbs 6 lbs 5 lbs 3.5 lbs 5.3 lbs N/A
Total Filtration >1.6 mmAI (Inherent Filtration: 0.8 mmAl, Fixed added filter: 0.7 mmAl) >1.5 mmAI equivalent 1.5 mmAI minimum Inherent Filtration: 0.8 mm Al, Fixed Added Filtration: 1.0 mm Al 1.7 mm AI
Warranty 1 Year – with 5 year Extended warranty Option 12 months Limited Warranty

*$495.00 5 Year Extended

 12 Month Warranty covering repairs and overnight Loaner 2 year Limited Warranty 2 Years Parts Warranty 90 day Parts and Labor Warranty then Repair warranty for 2 years 2 years