The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Cedars-sinai Quantitive Thallium 201 Analysis.
| Device ID | K932701 |
| 510k Number | K932701 |
| Device Name: | CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS |
| Classification | Camera, Scintillation (gamma) |
| Applicant | NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda, CA 92686 |
| Contact | Van Train |
| Correspondent | Van Train NUCCARDIAC SOFTWARE, INC. 20503 YORBA LINDA BLVD. SUITE 442 Torba Linda, CA 92686 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1994-03-29 |