K896609 is an FDA 510(k) clearance for the CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on January 31, 1990, 175 days after receiving the submission on August 9, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K896609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1989 |
| Decision Date | January 31, 1990 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |