SC-1000 With Suffixes (Scan Converter)
by Eigen
510(k) K890745
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890745 | Date14 Mar 1989 | 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- Withdrawn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, 21 Sep 2026
The Sc-1000 With Suffixes (Scan Converter) is a System, X-Ray, Fluoroscopic, Image-Intensified device. It is a Class 2 device used in the medical specialty of Radiology.
The device is supplied with a product code of JAA and is regulated under regulation number 892.1650. It has been issued FDA 510(k) clearance, with a decision of Substantially Equivalent, and has a device class of 2. The device was cleared on March 14, 1989.
Other devices from Eigen
Questions
AI-generated answers, 21 Sep 2026
What is the SC-1000 Scan Converter used for?
The SC-1000 Scan Converter is used in the medical specialty of Radiology for X-Ray fluoroscopy.
What is the regulatory classification of the SC-1000 Scan Converter?
The SC-1000 Scan Converter is a Class 2 device, regulated under regulation number 892.1650.
Is the SC-1000 Scan Converter cleared by the FDA?
Yes, the SC-1000 Scan Converter was cleared by the FDA on March 14, 1989, with a decision of Substantially Equivalent.