The following data is part of a premarket notification filed by Ischemaview Incorporated with the FDA for Rapid Ich.
| Device ID | K193087 |
| 510k Number | K193087 |
| Device Name: | Rapid ICH |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | iSchemaView Incorporated 433 Park Point Dr., Ste. 220 Golden, CO 80401 |
| Contact | James Rosa |
| Correspondent | James Rosa iSchemaView Incorporated 433 Park Point Dr., Ste. 220 Golden, CO 80401 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-06 |
| Decision Date | 2020-03-31 |
| Summary: | summary |