The following data is part of a premarket notification filed by Ischemaview, Inc. with the FDA for Ischemaview Rapid.
| Device ID | K182130 |
| 510k Number | K182130 |
| Device Name: | ISchemaView RAPID |
| Classification | System, Image Processing, Radiological |
| Applicant | iSchemaView, Inc. 201 Marshall Street, Ste. 101 Redwood City, CO 94063 |
| Contact | Jim Rosa |
| Correspondent | Jim Rosa iSchemaView, Inc. 433 Park Point Drive, Suite 220 Golden, CO 80401 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2018-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B761RAPID48302 | K182130 | 000 |
| B761RAPID49101 | K182130 | 000 |
| B7671R521 | K182130 | 000 |
| B7671R520 | K182130 | 000 |
| B7671R512 | K182130 | 000 |
| B7671R511 | K182130 | 000 |
| B761R5701 | K182130 | 000 |