The following data is part of a premarket notification filed by Cirs, Inc. with the FDA for Series Of Diagnostic Phantoms.
| Device ID | K834465 |
| 510k Number | K834465 |
| Device Name: | SERIES OF DIAGNOSTIC PHANTOMS |
| Classification | Phantom, Anthropomorphic, Radiographic |
| Applicant | CIRS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IXG |
| CFR Regulation Number | 892.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-20 |
| Decision Date | 1984-02-21 |