(129 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices in medical imaging.
No
The device is described as an "X-Ray System" used for "taking diagnostic extraoral dental x-rays," which is a diagnostic imaging function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states the device is used for "taking diagnostic extraoral dental x-rays."
No
The device description explicitly states it is a "Cordless Portable Dental X-Ray System," which is a hardware device that takes x-rays. The summary does not mention any software component as the primary or sole medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body. They are used in vitro (outside the body) to provide information about a person's health.
- The ADX400W Cordless Portable Dental X-Ray System is used to take images of the human body (specifically, dental structures) in vivo (within the body). It is a medical imaging device, not a diagnostic test performed on a specimen.
The intended use clearly states it's for "taking diagnostic extraoral dental x-rays," which is a form of medical imaging.
N/A
Intended Use / Indications for Use
The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.
Product codes
MUH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
Dental (extraoral)
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Trained and qualified dentists or dental technicians
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2014
Dexcowin Co. Ltd. % Mr. Claude Berthoin President Denterprise International, Inc. 110 East Granada Blvd., Suite 207 ORMOND BEACH FL 32176
Re: K134055
Trade/Device Name: ADX4000W Portable X-ray System Regulation Number: 21 CFR 872,1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 26, 2014 Received: April 10, 2014
Dear Mr. Berthoin:
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, 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 - Mr. Claude Berthoin
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
ı
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K134055
Device Name ADX4000W Portable X-Ray System
Indications for Use (Describe)
The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 807 Subpart C) | |
|---|---|---|
| -- | -------------------------------------------------- | --------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.7)
FORM FDA 3881 (6/13)
Type of Use (Select one or both, as applicable)
PSC Publishing Scriens (101) 443-6740 EF
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