K911082 is an FDA 510(k) clearance for the REAL TIME X-RAY IMAGING SYSTEM. This device is classified as a Digitizer, Image, Radiological (Class II - Special Controls, product code LMA).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on May 1, 1991, 51 days after receiving the submission on March 11, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2030.
| 510(k) Number | K911082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1991 |
| Decision Date | May 01, 1991 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | LMA — Digitizer, Image, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2030 |