The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Cedars-sinai Quantitative Ti-201 Analysis Ctq 2.0.
| Device ID | K905222 |
| 510k Number | K905222 |
| Device Name: | CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0 |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1990-12-26 |