The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Ultrafast Ct Scanner; Ebt Ct Scanner, Evolution.
| Device ID | K972879 |
| 510k Number | K972879 |
| Device Name: | ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION |
| 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 | 1997-08-05 |
| Decision Date | 1997-10-15 |
| Summary: | summary |