K033712 is an FDA 510(k) clearance for the MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Sectra-Imtec AB (Denton, US). The FDA issued a Cleared decision on December 23, 2003, 27 days after receiving the submission on November 26, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K033712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2003 |
| Decision Date | December 23, 2003 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |