(70 days)
Not Found
Not Found
No
The summary describes a digital X-ray sensor and associated software for image display, but there is no mention of AI or ML being used for image interpretation, analysis, or any other function. The software is explicitly stated as "not part of this product" and its function is described as basic image interpretation and display.
No
The device is an imaging sensor used to acquire X-ray images for diagnosis, and it does not directly treat a disease or condition.
No
The document states the device provides X-ray images which are then used for diagnosis by software and interpreted by a user. The device itself is a detector and data transmitter, not a diagnostic tool that performs the interpretation or decision-making.
No
The device description explicitly states that the product is a "digital x-ray sensor system" and that the "X-ray energy is detected by the sensor and transmitted as data to the computer". This indicates the product includes a physical sensor component, which is hardware, not software. The software is mentioned as a separate component ("not part of this product").
Based on the provided information, the Accent Sensor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Accent Sensor is an X-ray sensor used to capture images of teeth, bone, and surrounding tissues within the body. It does not analyze biological samples.
- The description focuses on imaging technology. The device description clearly outlines how the sensor detects X-ray energy and transmits data for image display. This is characteristic of an imaging device, not an IVD.
- The intended use is for imaging and diagnosis based on those images. The purpose is to provide "instant Xray images" for "diagnosis," which is a function of medical imaging, not in vitro diagnostics.
Therefore, the Accent Sensor falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues. Accent replaces standard X-ray film and/or phosphor plate technology.
Product codes
MUH
Device Description
The Accent Sensor is a digital x-ray sensor system. The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Teeth, bone and surrounding tissues (dental, medical and veterinary applications)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2005
Mr. Joseph Carey Director of Quality Assurance Air Techniques, Inc. Corporate Headquarters 70 Cantiague Rock Road P.O. Box 870 HICKSVILLE NY 11801
Re: K050693 Trade/Device Name: Accent Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 4, 2005 Received: May 5, 2005
Dear Mr. Carey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your coursel s substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholosure) to regally mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the charmers 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 approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 n your de 10 the subject to such additional controls. Existing major regulations affecting your Apployally, it they of below 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 I toase be devilod that i 211 in that your device complies with other requirements of the Act or any I DA ilas made a acteriminations administered by other Federal agencies. You must comply with all the r carrar status and regulating, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, metaling practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin hancellig your intil equivalence of your device to a legally premarket notification. The PDA midnig of Saccannal Systems and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our lateling regulation (21 CFR Part 801), please If you desire specific advice for your cerres on our be subjects, 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 prematic notification under the Act from the Also, please note the regulation entired, "Thisonalians of your responsibilities under the Act from the 807.97). You may obtain other general mornation on your copying in the toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
ltem 10 STATEMENT OF INDICATIONS FOR USE:
510K Number (if known): ___
Device Name: Accent
The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.
KOSO693
Accent replaces standard X-ray film and/or phosphor plate technology.
The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over the counter use (Optional Format 1-2-96)
Nancy C Brazdon
510K – Accent, March 16, 2005
(Division Sign-Off Chansion of Reproductive, Abdominal, Page 7 of 11 a .. Padiological Devices 205064 510(k) Number