K914376 is an FDA 510(k) clearance for the DXS DIGITAL X-RAY SUBTRACTION. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on February 4, 1992, 126 days after receiving the submission on October 1, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K914376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1991 |
| Decision Date | February 04, 1992 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |