(101 days)
Not Found
No
The document describes a standard dental X-ray system and does not mention any AI or ML capabilities.
No
The device is used for taking diagnostic dental X-rays, which falls under diagnostic imaging, not therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is "for taking diagnostic extraoral dental X-rays." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "battery-powered hand-held dental x-ray machine," indicating it is a hardware device that generates X-rays.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ADX4000 Cordless Portable Dental X-ray System is a device that generates X-rays to create images of the teeth and surrounding structures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "taking diagnostic extraoral dental X-rays using intraoral digital sensors or film." This is an imaging procedure, not an in vitro test.
Therefore, based on the provided information, the ADX4000 is a medical imaging device, specifically a dental X-ray system, and not an IVD.
N/A
Intended Use / Indications for Use
The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors.
Product codes
MUH
Device Description
The DexcoWinA ADX4000 Cordless Portable Dental X-ray System is a battery-powered hand-held dental x-ray machine whose fixed output is 60 kVo (Constant Potential). It can be used with either a digital sensor or conventional film. This is a prescription device that can be used on pediatric and adult patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
Dental/intraoral
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
trained and qualified dentists or dental technician
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K070811.st
510(k) Summary
031
DexcoWinA ADX4000 Cordless Portable Dental X-ray System
Common/Classification Name:
JUL - 5 2007
Unit, X-Ray, Extraoral With Timer
21 CFR 872.1800
Sponsor:
Dexco Attn: Henry Jang, Vice-President 1102, 31d E&C Venture Dream Tower 197-33 Guo-dong, Guro-gu Seoul (South) Korea
Contact:
RegTech Solutions, LLC; Attn: Robert Mazzaferro, Manager 11 Dellcastle Court; Montgomery Village, MD 20886
Prepared: March 20, 2007
LEGALLY MARKETED PREDICATE DEVICE
For its indication for use, the DexcoWinA ADX4000 Cordless Portable Dental X-ray System is substantially equivalent to the Nomad Dental X-ray System cleared by FDA under K051795.
DEVICE DESCRIPTION
The DexcoWinA ADX4000 Cordless Portable Dental X-ray System is a battery-powered hand-held dental x-ray machine whose fixed output is 60 k Vo (Constant Potential). It can be used with either a digital sensor or conventional film. This is a prescription device that can be used on pediatric and adult patients.
SUBSTANTIAL EQUIVALENCE SUMMARY
A comparison of the Dexco WinA ADX4000 Cordless Portable Dental X-ray System and the Nomad™ Dental X-ray System is presented in Table 1.
1
| Feature | DexcoWinA ADX4000 (New Device) | NOMAD™ (Predicate Device K051795) |
|---|---|---|
| INTENDED USE: | The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors. | The NOMAD Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subject as an extraoral diagnostic dental x-ray sources to produce X-ray images using intraoral image receptors. |
| MECHNICAL: | ||
| Size: Body | 5.5"H x 6.5"W x 3.2"D | 13"L x 11.5"H x 5.5"W |
| Weight | 4.4lbs. | 8.5lbs |
| Source to skin distance | 20cm | 20cm |
| Cone diameter | 5cm | 6cm |
| User Interface | Up-down and left-right buttons for exposure time selections with display | Up-down buttons for exposure time selections, with timer display |
| Backscatter radiation protection | Circular scatter shield | 6.75"dia. Pb-filled acrylic plastic scatter shield |
| Exposure switch | On tubehead assembly, or at control panel | On tubehead assembly/ control panel |
| Tubehead mounting | Handheld, or on a tripod | Handheld |
| ELECTRICAL: | ||
| Energy Source | Rechargeable 16.8V DC Li-Polymer battery pack | Rechargeable 14.4V DC NiCd battery pack |
| Exposure Time | 0.01-1.35 seconds in 0.01 increments | 0.01-0.99 seconds in 0.01 increments |
| Timer Accuracy | $\pm$ (10% + 1ms) | $\pm$ (10%+1ms) |
| mA | 1mA fixed | 2.3mA fixed |
| kVp | 60kVp fixed | 60kVp fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical Safety Standards | IEC60601-1 & others | IEC60601-1 & others. |
| Electromagnetic Standards | EN60601-1-2 & others | IEC60601-1-2 |
| X-RAY PERFORMANCE | 21 CFR 1020.30, 1020.31 | |
| IEC60601-1-3 | 21 CFR 1020.30, 1020.31 | |
| IEC60601-1-3 | ||
| IEC60601-2-7 |
CONCLUSION
As can be seen in the comparison table above the DexcoWinA ADX4000 & its suggested predicate, the Nomad, have the same intended use and are nearly technically the same. We therefore believe that the ADX4000 is substantially equivalent to the Nomad.
. 032
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Image /page/2/Picture/0 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure with three arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 5 2007
DexcoWinA % Mr. Robert Mazzaferro Manager RegTech Solutions, LLC 11 Dellcastle Court MONTGOMERY VILLAGE MD 20886
Re: K070811
Trade/Device Name: ADX4000 Cordless Portable Dental X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 18, 2007 Received: June 18, 2007
Dear Mr. Mazzafferro:
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 commence prior to May 28, 1976, 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 movi. therefore, market the device, subject to the general controls provisions of the Act. The grateral 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 Approval), 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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters FDA in a bold, stylized font. The text is slightly blurred, suggesting it may be part of a larger document or image.
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 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) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely vours.
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
Indications for Use
510(k) Number (if known):
AND/OR
Device Name: ADX4000 Cordless Portable Dental X-ray System
Indications for Use: The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and bediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital sensors or film.
× Prescription Use (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1.
Helena Lewin
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number