The following data is part of a premarket notification filed by Image Enhancements with the FDA for Qct Bone Mineral Density Analysis Software.
| Device ID | K894854 |
| 510k Number | K894854 |
| Device Name: | QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE |
| Classification | Densitometer, Bone |
| Applicant | IMAGE ENHANCEMENTS 564 MISSION ST., #236 San Francisco, CA 94105 |
| Contact | Audie Chason |
| Correspondent | Audie Chason IMAGE ENHANCEMENTS 564 MISSION ST., #236 San Francisco, CA 94105 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B052QCTPROM3SS0 | K894854 | 000 |
| B052DIQCTPRO0 | K894854 | 000 |