Koordinant Angiographic and Operating Room Model X-Ray Table Family
510(k) K993947
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993947 | Date21 Dec 1999 | 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- Withdrawn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
- IZI
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1600
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Koordinant Angiographic and Operating Room Model X-Ray Table Family is a floor-mounted table designed to support and position patients during angiographic procedures and surgery. It features an X-ray translucent tabletop to facilitate imaging and is operated by clinical staff in angiographic suites or operating rooms.
The device is supplied as a reusable system and is classified as a Class II medical device under FDA regulation number 892.1600. It received FDA 510(k) clearance (K993947) on December 21, 1999, as substantially equivalent to a predicate device, and is manufactured by Siemens Corp. in Iselin, New Jersey.
Other devices from Siemens Corp.
Questions
AI-generated answers, 6 Oct 2026
What is the Koordinant Angiographic and Operating Room Model X-Ray Table Family used for?
The Koordinant Angiographic and Operating Room Model X-Ray Table Family is designed to support and position patients during angiographic procedures and surgery, featuring an X-ray translucent tabletop to facilitate imaging in angiographic suites or operating rooms.
How is the Koordinant Angiographic and Operating Room Model X-Ray Table Family supplied and is it reusable?
The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and reprocessing, and is not a single-use product.
What regulatory pathway was used for the Koordinant Angiographic and Operating Room Model X-Ray Table Family?
The Koordinant Angiographic and Operating Room Model X-Ray Table Family received FDA 510(k) clearance (K993947) on December 21, 1999, as substantially equivalent to a predicate device under regulation number 892.1600.