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 |