The following data is part of a premarket notification filed by Imbio, Llc with the FDA for Imbio Rv/lv Software.
| Device ID | K203256 |
| 510k Number | K203256 |
| Device Name: | Imbio RV/LV Software |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Imbio, LLC 1015 Glenwood Avenue, Floor 4 Minneapolis, MN 55405 |
| Contact | William Mclain |
| Correspondent | William Mclain Imbio, LLC 1015 Glenwood Avenue, Floor 4 Minneapolis, MN 55405 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2021-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850894007605 | K203256 | 000 |
| 00850894007636 | K203256 | 000 |
| 00850894007643 | K203256 | 000 |
| 00850894007728 | K203256 | 000 |
| 00850894007766 | K203256 | 000 |