The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Ebt Ultrafast Ct Scanner System; Ultrafast Ct Scanner System; C-100, C-150, C-150lxp Or C-150xp Scanner Systems.
| Device ID | K992740 |
| 510k Number | K992740 |
| Device Name: | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS |
| 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 | 1999-08-16 |
| Decision Date | 1999-11-09 |
| Summary: | summary |