Telamat
by Comet Ltd. C/O Radiology Resources, Inc.
510(k) K864749
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864749 | Date10 Feb 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Telamat is an image-intensified, fluoroscopic X-ray system. It is classified as a Class II medical device used in the field of radiology.
This device was cleared via the FDA 510(k) process under K864749. It is regulated under the product code JAA and regulation number 892.1650.
Other devices from Comet Ltd. C/O Radiology Resources, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the primary use of the Telamat system?
The Telamat is an image-intensified, fluoroscopic X-ray system designed for use within the field of radiology to assist in diagnostic imaging procedures.
How was the Telamat authorized for use?
The device was cleared through the FDA 510(k) process, identified by submission number K864749, where it was determined to be substantially equivalent to existing devices.
What is the regulatory classification of this device?
The Telamat is classified as a Class II medical device. It is regulated under product code JAA and regulation number 892.1650, which pertains to image-intensified fluoroscopic X-ray systems.