The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Imatron Ultra Access Workstation With Cardiac Software Extensions.
| Device ID | K972903 |
| 510k Number | K972903 |
| Device Name: | IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | IMATRON, INC. 389 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Contact | J.a. Coduto |
| Correspondent | J.a. Coduto IMATRON, INC. 389 OYSTER POINT BLVD. 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 | 1997-08-06 |
| Decision Date | 1997-11-04 |
| Summary: | summary |