The following data is part of a premarket notification filed by Imaging Therapeutics, Inc. with the FDA for Osdx Hip Bmd System.
| Device ID | K082402 |
| 510k Number | K082402 |
| Device Name: | OSDX HIP BMD SYSTEM |
| Classification | Densitometer, Bone |
| Applicant | IMAGING THERAPEUTICS, INC. 400 SEAPORT COURT, SUITE 250 Redwood City, CA 94063 |
| Contact | Patrick Hess |
| Correspondent | Patrick Hess IMAGING THERAPEUTICS, INC. 400 SEAPORT COURT, SUITE 250 Redwood City, CA 94063 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-20 |
| Decision Date | 2008-10-16 |
| Summary: | summary |