K923481 is an FDA 510(k) clearance for the PHILIPS LASER DISK ARCHIVE. This device is classified as a Camera, Multi Format, Radiological (Class II - Special Controls, product code LMC).
Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on May 5, 1993, 294 days after receiving the submission on July 15, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2040.
| 510(k) Number | K923481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1992 |
| Decision Date | May 05, 1993 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LMC — Camera, Multi Format, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2040 |