The following data is part of a premarket notification filed by Computerized Imaging Reference Systems, Inc. with the FDA for Tissue-equivalent Breast Simulator.
| Device ID | K865100 |
| 510k Number | K865100 |
| Device Name: | TISSUE-EQUIVALENT BREAST SIMULATOR |
| Classification | Test-pattern, Radiographic |
| Applicant | COMPUTERIZED IMAGING REFERENCE SYSTEMS, INC. 2488B ALMEDA AVE. Norfolk, VA 23513 |
| Contact | William R Drury |
| Correspondent | William R Drury COMPUTERIZED IMAGING REFERENCE SYSTEMS, INC. 2488B ALMEDA AVE. Norfolk, VA 23513 |
| Product Code | IXF |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-30 |
| Decision Date | 1987-01-12 |