The following data is part of a premarket notification filed by Computerized Imaging Reference Systems, Inc. with the FDA for Bone Density Ct Phantom.
| Device ID | K852528 |
| 510k Number | K852528 |
| Device Name: | BONE DENSITY CT PHANTOM |
| Classification | Phantom, Anthropomorphic, Radiographic |
| Applicant | COMPUTERIZED IMAGING REFERENCE SYSTEMS, INC. 2488B ALMEDA AVE. Norfolk, VA 23513 |
| Contact | W. R Drury |
| Correspondent | W. R Drury COMPUTERIZED IMAGING REFERENCE SYSTEMS, INC. 2488B ALMEDA AVE. Norfolk, VA 23513 |
| Product Code | IXG |
| CFR Regulation Number | 892.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-14 |
| Decision Date | 1985-09-26 |