K941566 is an FDA 510(k) clearance for the COMPUSPEAK. This device is classified as a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on June 30, 1995, 455 days after receiving the submission on April 1, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K941566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1994 |
| Decision Date | June 30, 1995 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| 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 |