(70 days)
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Not Found
No
The description focuses on the scanning and storage of images, with no mention of AI/ML, image processing beyond display, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a scanner for dental x-ray images, used for display and storage, not for treating any condition or disease.
No
The device digitizes x-ray images but does not provide diagnostic insights or interpretations. Its function is to convert physical plates into digital images for display and storage.
No
The device description explicitly states it is a "device that scans photostimulable phosphor plates," which indicates it is a hardware device with scanning capabilities, not solely software.
Based on the provided information, the ScanX Scanner 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.
- ScanX Function: The ScanX Scanner processes images from photostimulable phosphor plates that have been exposed to dental x-rays. It is used to display and store these images.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from a patient. Its function is solely related to processing and displaying medical images.
Therefore, the ScanX Scanner falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
Product codes
MUH
Device Description
The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and authorized dental auxiliary personnel
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
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/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular with text around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Mr. Joseph Carey Director of Quality Assurance Air Techniques, Inc. Corporate Headquarters 70 Cantiague Rock Road P.O. Box 870 HICKSVILLE NY 11801
Re: K013893
Trade/Device Name: SCANX Scanner Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: November 20, 2001 Received: November 23, 2001
Dear Mr. Carey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the chorosaly to regary coment date of the Medical Device Amendments, or to commence proc to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have been rochasined in assee approval of a premarket approval application (PMA). allo Costietic Act (71ct) that ao not requently of the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (see above) in Existing major regulations affecting your device can be it may be subject to additional conditions, 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 I lease oc advised that I Dris issualites our device complies with other requirements of the Act that I DA has made a acterimistions administered by other Federal agencies. You must of any I ederal battle Act's requirements, including, but not limited to: registration and listing compry with and he rece requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (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 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by received to promation the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
2
Page Page of
ltem 10 STATEMENT OF INDICATIONS FOR USE:
510K Number (if known): _ KO13893
Device Name: ScanX Scanner
The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use or Over the counter use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Air Techniques, Inc. VistaRay Scanner 510K, November 16, 2001