The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Ct Cardiac Function Analysis Software, Models Cscf-001a And Cscf-001b.
| Device ID | K023760 |
| 510k Number | K023760 |
| Device Name: | CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Paul Biggins |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-11-08 |
| Decision Date | 2002-11-22 |
| Summary: | summary |