The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for X-caliber Model 1000 Bone Mineral Analyzer.
| Device ID | K871553 |
| 510k Number | K871553 |
| Device Name: | X-CALIBER MODEL 1000 BONE MINERAL ANALYZER |
| Classification | Densitometer, Bone |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Alan Hochberg |
| Correspondent | Alan Hochberg HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-22 |
| Decision Date | 1987-10-08 |