K800554 is an FDA 510(k) clearance for the MULTI-FORMAT SFD MODEL 1720. This device is classified as a Device, Spot-film (Class II - Special Controls, product code IXL).
Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980, 29 days after receiving the submission on March 12, 1980.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1670.
| 510(k) Number | K800554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1980 |
| Decision Date | April 10, 1980 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXL — Device, Spot-film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1670 |