(56 days)
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Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices (like training/test sets, AUC, sensitivity/specificity related to algorithmic performance). The description focuses solely on the device's function as a digital x-ray sensor for dental imaging.
No
The device is described as being for "examination and diagnosis," which are diagnostic rather than therapeutic purposes.
Yes
The device is intended for "diagnosis of the teeth, jaw and oral structure," which explicitly states a diagnostic purpose.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, the CDMx-H is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images." This describes a device used for in vivo imaging and diagnosis of a patient's anatomy, not for testing samples taken from the body (which is the core of in vitro diagnostics).
- Input: The input is "scanned dental x-ray images," which are images of a patient's internal structures, not biological samples.
- Anatomical Site: The anatomical site is "teeth, jaw and oral structure," which are parts of the living body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CDMx-H operates on images of the patient's body directly.
N/A
Intended Use / Indications for Use
The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.
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
Scanned dental x-ray images
Anatomical Site
teeth, jaw, and oral structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Choi Director, Regulatory Affairs Camsight Co., Inc. 3380 San Fernando Road LOS ANGELES CA 90065
Re: K053221
JAN 1 2 2006
Trade/Device Name: CDMx-H Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 14, 2005 Received: November 23, 2005
Dear Mr. Choi:
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.
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.
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 clectronic 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) 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 n you t the 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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Higdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) number (if known):
page 1 of _1
Device Name: CDMx-H
Indications For Use:
The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of DCRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Davide Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_