The following data is part of a premarket notification filed by Whiterabbit.ai Inc. with the FDA for Wrdensity By Whiterabbit.ai.
| Device ID | K202013 |
| 510k Number | K202013 |
| Device Name: | WRDensity By Whiterabbit.ai |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Whiterabbit.ai Inc. 3930 Freedom Cir. Ste 101 Santa Clara, CA 95054 |
| Contact | Jason Su |
| Correspondent | Jason Su Whiterabbit.ai Inc. 3930 Freedom Cir. Ste 101 Santa Clara, CA 95054 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-21 |
| Decision Date | 2020-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005853601 | K202013 | 000 |