K100692 is an FDA 510(k) clearance for the DIGITAL SPOT MAMMOGRAPHY SYSTEM. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on April 6, 2010, 27 days after receiving the submission on March 10, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K100692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2010 |
| Decision Date | April 06, 2010 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |