The following data is part of a premarket notification filed by Qure.ai Technologies with the FDA for Qer.
| Device ID | K200921 |
| 510k Number | K200921 |
| Device Name: | QER |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Qure.ai Technologies Level 7, Commerz II, International Business Park, Oberoi Garden City, Mumbai, IN 400063 |
| Contact | Pooja Rao |
| Correspondent | Pooja Rao Qure.ai Technologies Level 7, Commerz II, International Business Park, Oberoi Garden City, Mumbai, IN 400063 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005118106 | K200921 | 000 |