The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Rtr-2000/rtr-4000.
| Device ID | K974307 |
| 510k Number | K974307 |
| Device Name: | RTR-2000/RTR-4000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TERARECON, INC. 280 UTAH AVE., SUITE 100 South San Francisco, CA 94080 |
| Contact | Tim Frandsen |
| Correspondent | Tim Frandsen TERARECON, INC. 280 UTAH AVE., SUITE 100 South San Francisco, CA 94080 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-02-13 |
| Summary: | summary |