NOMAD DENTAL X-RAY SYSTEM

K051795 · Aribex, Inc. · EHD · Jul 14, 2005 · Dental

Device Facts

• Record ID: K051795
• Device Name: NOMAD DENTAL X-RAY SYSTEM
• Applicant: Aribex, Inc.
• Product Code: EHD · Dental
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The NOMAD™ Dental X-ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Device Story

NOMAD™ Dental is a portable, handheld dental x-ray system. It integrates x-ray tubehead, controls, and power source into a single unit. Powered by a 14.4 V DC rechargeable NiCd battery pack. Features include a 6.75" diameter Pb-filled acrylic plastic backscatter shield to protect the operator. Operated by trained dentists or dental technicians in a clinical setting. The user selects exposure time via up-down buttons with a timer display. The device emits x-rays to produce diagnostic images on intraoral receptors. Portability allows for flexible positioning during dental imaging procedures, potentially improving workflow efficiency compared to fixed AC-powered systems.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technical specifications, including electrical safety standards (IEC60601-1, UL60601-1) and radiation performance standards (21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7).

Technological Characteristics

Handheld portable dental x-ray system. Energy source: 14.4 V DC rechargeable NiCd battery. Fixed output: 60 kVp, 2.3 mA. Exposure time: 0.01–0.99 seconds. Includes Pb-filled acrylic plastic backscatter shield. Standards: IEC60601-1, UL60601-1, EN60601-1, IEC60601-1-2, 21 CFR 1020.30/1020.31, IEC60601-1-3, IEC60601-2-7.

Indications for Use

Indicated for use by trained dentists or dental technicians for adult and pediatric patients as an extraoral diagnostic dental x-ray source to produce images using intraoral image receptors.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Portable HDX Intraoral X-ray system (K021378)

Submission Summary (Full Text)

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K051795

Image /page/0/Picture/1 description: The image shows the logo and contact information for ARIBEX. The logo features the company name in bold, black letters with a stylized graphic element. Below the logo is the company website, www.aribex.com. The contact information includes the address: 754 South 400 East, Orem, Utah 84097, USA, as well as the phone number: 801.226.5522 and fax number: 801.434.7233.

Tab 4

JUL 1 4 2005

510(k) Summary

NOMAD™ Dental Portable X-ray System June 13, 2005

- 1. Company:

| Name: | Aribex, Inc. |
|----------|--------------------------------------|
| Address: | 754 South 400 East<br>Orem, UT 84651 |

Official Correspondent: D. Clark Turner, PhD, CEO

Telephone No: 801-226-5522 801-434-7233 FAX No:

| 2. Proprietary – Trade Name: | NOMAD™ Dental X-ray System |
|------------------------------|------------------------------------------------------------|
| Classification Name: | Extraoral source x-ray system (per 21CFR section 872.1800) |
| Common/Usual Name: | Portable Dental X-ray System |

- 3. Predicate Device: Portable HDX Intraoral X-ray system, (K021378), manufactured by Flow X-Ray. Literature included at Tab 11.
- 4. Description: NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.
- 5. Intended Use: The NOMAD™ Dental X-ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

| Feature | Portable HDX<br>Intraoral X-ray<br>K021378 | NOMAD™ Dental<br>X-ray System |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| INTENDED USE: | Both systems are intended as extraoral x-ray sources to be used with<br>intraoral image receptors for diagnostic imaging by dentists or dental<br>technicians. | |

- Comparison with predicate device: 6.

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## 6. Comparison (continued)

| Feature | Portable HDX<br>Intraoral X-ray<br>K021378 | NOMAD™ Dental<br>Intraoral X-ray Source |
|-------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------|
| MECHANICAL: | | |
| Size: Body | 5.5"H x 8.25" W x 8" D | 13"L x 11.5"H x 5.5"W |
| Weight | 11.7 lbs. | 8.5 lbs. |
| Source to skin distance | 20 cm | 20 cm |
| Cone diameter | 6.3 cm | 6 cm |
| User Interface | Up-down buttons for exposure<br>time selections with display | Up-down buttons for exposure<br>time selection, with timer display |
| Backscatter radiation<br>protection | Circular scatter shield | 6.75" dia. Pb-filled acrylic plastic<br>scatter shield |
| Exposure switch | On tubehead assembly, or at<br>control panel | On tubehead assembly/ control<br>panel |
| Tubehead mounting | Handheld, or on a tripod | Handheld |
| ELECTRICAL: | | |
| Energy Source | 120 V 50/60 Hz or 240 V 50/60<br>Hz AC | Rechargeable 14.4 V DC NiCd<br>battery pack |
| Exposure Time | 0.01 – 2.00 seconds in 0.01<br>increments | 0.01 - 0.99 seconds in 0.01<br>increments |
| Timer Accuracy | ±(10% + 1ms) | ±(10% + 1ms) |
| mA | 7 mA fixed | 2.3 mA fixed |
| kVp | 65 kVp fixed | 60 kVp fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical Safety<br>Standards | UL 2601, CSA 601-M90,<br>EN60601-1: 1990+A1+A2 | IEC60601-1, UL60601-1,<br>EN60601-1 |
| EMI Standards | IEC60601-1-2 | IEC60601-1-2 |
| X-RAY<br>PERFORMANCE: | | |
| Performance Standard | 21 CFR 1020.30 | 21 CFR 1020.30, 1020.31<br>IEC60601-1-3<br>IEC60601-2-7 |

#### 7. Conclusion:

The only significant technological difference, DC battery power versus AC line voltage, has no bearing on safety or effectiveness of the new device. Since inte voltage, has no boaining on balely in is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 4 2005

Aribex, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K051795 Trade/Device Name: NOMAD™ Dental X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 1, 2005 Received: July 5, 2005

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one reviewed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholors, to e enactment date of the Medical Device Amendments, or to devices that have been reay 20, 1970, all clares with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approvisions of the Act. The general controls provisions of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your al), it may be subject to such additional controls. Existing major regulations affecting your I tpp. o an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
The States will and and on the best of a location at the squice to a legally This letter will allow you to begin maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. The PDA miding of Substantial off.
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring regionation (
contact the Office of Compliance at one of the following numbers, based on the regulation number a the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "firstnation on your responsibilities under the Act from the 807.97). You may obtain other geleral information on your repeared its toll-free number (800) Division or [phone] or at its Internet address 058-2041 of (501) vicdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Tab 3

## Indications For Use

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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Device Name: NOMAD™ DENTAL X-ray System

Indications for Use: The NOMAD™ DENTAL X-ray System is indicated for use Indications for USe. The NOM/ - Dental technician for both adult and the only by a trained and qualified dentist of dontal coomist.
pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051795

Prescription Use_X (per 21CFR801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________