The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Tissue Mimicking Ultrasound Phantoms.
| Device ID | K834482 |
| 510k Number | K834482 |
| Device Name: | TISSUE MIMICKING ULTRASOUND PHANTOMS |
| Classification | Test-pattern, Radiographic |
| Applicant | RADIATION MEASUREMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IXF |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-15 |
| Decision Date | 1984-01-25 |