The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Computed Tomography Calibration Phant.
| Device ID | K840131 |
| 510k Number | K840131 |
| Device Name: | COMPUTED TOMOGRAPHY CALIBRATION PHANT |
| Classification | Phantom, Anthropomorphic, Radiographic |
| Applicant | IMATRON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IXG |
| CFR Regulation Number | 892.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-10 |
| Decision Date | 1984-02-21 |