K871553 is an FDA 510(k) clearance for the X-CALIBER MODEL 1000 BONE MINERAL ANALYZER. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Hologic, Inc. (Waltham, US). The FDA issued a Cleared decision on October 8, 1987, 169 days after receiving the submission on April 22, 1987.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K871553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1987 |
| Decision Date | October 08, 1987 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KGI — Densitometer, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1170 |