(10 days)
K0063121, K051795
Not Found
No
The summary describes a standard handheld dental X-ray system and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No.
The device is described as an X-ray system intended for producing diagnostic images, not for therapy or treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "for producing diagnostic X-ray images" and "as an extraoral diagnostic dental X-ray source".
No
The device description clearly states it is a handheld dental X-ray system with hardware components like an X-ray tubehead, controls, power source, battery, charging cradle, and power supply.
Based on the provided information, the NOMAD Pro X-ray System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the NOMAD Pro X-ray System is an extraoral X-ray source used to produce diagnostic X-ray images of the patient (specifically, dental images). It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on the hardware for generating X-rays. It describes the X-ray tubehead, power source, and controls, which are components of an imaging system, not a diagnostic test performed on a specimen.
Therefore, the NOMAD Pro X-ray System falls under the category of a medical imaging device, specifically a dental X-ray system.
N/A
Intended Use / Indications for Use
The NOMAD Pro 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.
The NOMAD Pro X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce Xray images using intraoral image receptors.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
trained dentists and dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K0063121, K051795
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
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.(b)
Classification. Class II.
0
K081664
pg. 1 of 2
Tab 4
510(k) Summary
JUN 2 3 2008
NOMAD Pro Handheld X-ray System 30 May 2008
1. Company:
| Name: | Aribex, Inc. |
|---|---|
| Address: | 744 South 400 East |
| 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 Pro X-ray System |
|---|---|
| Classification Name: | Extraoral source X-ray system (per 21CFR section 872.1800) |
| Common/Usual Name: | Handheld Dental X-ray System |
Predicate Device: Port-X II Portable X-ray System, 510(k) # K0063121, manufactured by Genorav, and the NOMAD Dental X-ray System, 510(k) #K051795. manufactured by Aribex. Literature included at Tab 12.
-
- Description: NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.
-
- Intended Use: The NOMAD Pro 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.
1
K081664
pg. 2 of 2
5. Comparison with predicate devices:
| Feature | Genoray Port-X II
K063121 | NOMAD Dental
Intraoral X-ray Source
K051795 | NOMAD Pro
Intraoral X-ray Source |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | All three systems are intended as extraoral X-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. | | |
| MECHANICAL: | | | |
| Size: Body | 7.8" x 5.8" x 3.7" | 13"L x 11.5"H x 5.5"W | 10.5"L x 12"H (including shield) x 5.25"W |
| Weight | 5.2 lbs | 8.5 lbs. | 5.3 lbs. |
| Source to skin distance | 10 cm | 20 cm | 21 cm |
| Cone diameter | 7 cm | 6 cm | 6 cm |
| User Interface | Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size and tooth selection icons on an LCD display. | Up-down buttons for exposure time selection, with timer display. | Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size, image-receptor type, and tooth selection icons on an LCD display. |
| Backscatter radiation protection | None | 6.75" dia. Pb-filled acrylic plastic scatter shield | 6.75" dia. Pb-filled acrylic plastic scatter shield |
| Exposure switch | Exposure button at x-ray control panel | Trigger on tubehead assembly and Start button on control panel | Trigger on Handset |
| Tubehead mounting | Handheld, or on a tripod | Handheld | Handheld |
| ELECTRICAL: | | | |
| Energy Source | Rechargeable 22.2 V DC Lithium Polymer battery pack | Rechargeable 14.4 V DC NiCd battery pack | Rechargeable 22.2 V DC Lithium Polymer battery pack |
| Exposure Time | 0.01 – 2.0 seconds in 46 steps | 0.01 – 0.99 seconds in 0.01 increments | 0.02 – 1.00 seconds in 0.01 increments |
| Timer Accuracy | ±(10% + 1ms) | ±(10% + 1ms) | ±(10% + 1ms) |
| mA | 2 mA fixed | 2.3 mA fixed | 2.5 mA fixed |
| kVp | 60 kV fixed | 60 kVp fixed | 60 kVp fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | (not available) | 1:60 | 1:60 |
| Electrical Safety Standards | EN60601-1 | IEC60601-1, UL60601-1, EN60601-1 | IEC60601-1, EN60601-1 |
| EMI Standards | EN60601-1-2 | IEC60601-1-2 | EN60601-1-2 |
| X-RAY PERFORMANCE: | | | |
| Performance Standard | EN60601-1-3
EN60601-2-7
EN60601-2-28
EN60601-2-32 | 21 CFR 1020.30, 1020.31
IEC60601-1-3
IEC60601-2-7 | 21 CFR 1020.30, 1020.31
IEC60601-1-3
IEC60601-2-7 |
-
- Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Aribex, Inc. concludes that the NOMAD Pro Portable X-ray System is safe and effective and substantially equivalent to predicate devices as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2008
Aribex, Inc. c/o Mr. Morten Simon Christensen Staff Engineer/Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
Re: K081664
Trade/Device Name: NOMAD Pro X-ray System Regulation Number: 21 CFR 8872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: June 10, 2008 Received: June 13, 2008
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 May 28, 1796, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance 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 device, subject to the general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can 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.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/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
4
Tab 3
Indications For Use
K. 081664 510(k) Number:
Device Name: NOMAD Pro X-ray System
Indications for Use: The NOMAD Pro X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce Xray 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)
Vorzu M. Whan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use X
(per 21CFR801.109)
OR
Over-The-Counter Use
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