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 |