The following data is part of a premarket notification filed by Ischemaview Inc. with the FDA for Rapid Aspects.
| Device ID | K200760 |
| 510k Number | K200760 |
| Device Name: | Rapid ASPECTS |
| Classification | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Applicant | iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden, CO 80401 |
| Contact | Jim Rosa |
| Correspondent | Jim Rosa iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden, CO 80401 |
| Product Code | POK |
| CFR Regulation Number | 892.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-24 |
| Decision Date | 2020-06-26 |