K913757 is an FDA 510(k) clearance for the HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on October 30, 1991, 70 days after receiving the submission on August 21, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K913757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1991 |
| Decision Date | October 30, 1991 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |