The following data is part of a premarket notification filed by Ischema View, Inc. with the FDA for Ischema View Rapid.
| Device ID | K121447 |
| 510k Number | K121447 |
| Device Name: | ISCHEMA VIEW RAPID |
| Classification | System, Image Processing, Radiological |
| Applicant | ISCHEMA VIEW, INC. 5405 ALTON PARKWAY 5A, #530 Irvine, CA 92604 |
| Contact | Marc Goodman |
| Correspondent | Marc Goodman ISCHEMA VIEW, INC. 5405 ALTON PARKWAY 5A, #530 Irvine, CA 92604 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2013-10-04 |
| Summary: | summary |