Omnitron GYN Applicator System
510(k) K913908
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913908 | Date6 Mar 1992 | 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- Withdrawn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
- JAQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5700
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Omnitron GYN Applicator System is a medical device classified as a System, Applicator, Radionuclide, Remote-Controlled. It is designed for use in radiology procedures involving radionuclide applications.
The device is supplied as a single-use system and is intended for use by healthcare professionals. It is not specified as MRI safe. The device is regulated under FDA 510(k) clearance, with a product code of JAQ.
Other devices from Omnitron Intl., Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Omnitron GYN Applicator System used for?
This device is a remote-controlled applicator for radionuclide applications used in radiology procedures.
Is the Omnitron GYN Applicator System a single-use device?
Yes, the device is supplied as a single-use system for use by healthcare professionals.
Is the Omnitron GYN Applicator System MRI safe?
No, the device is not specified as MRI safe.
How is the Omnitron GYN Applicator System regulated?
The device is regulated under FDA 510(k) clearance with a product code of JAQ.