The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Ebt Ultrafast Ct Scanner System; C-100, C-150, C-150lxp Or C-150xp Scanner Systems; Electron Beam Scanner System; Electr.
| Device ID | K001550 |
| 510k Number | K001550 |
| Device Name: | EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-12-11 |