The following data is part of a premarket notification filed by Ai Metrics, Llc with the FDA for Ai Metrics.
Device ID | K202229 |
510k Number | K202229 |
Device Name: | AI Metrics |
Classification | System, Image Processing, Radiological |
Applicant | AI Metrics, LLC 432 Renaissance Dr. Hoover, AL 35226 |
Contact | Andrew D. Smith |
Correspondent | Yujan Shrestha Innolitics, LLC 1101 West 34th St #550 Austin, TX 78705 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-07 |
Decision Date | 2020-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
G090AIM11 | K202229 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() AI METRICS 88763565 not registered Live/Pending |
AI Metrics, LLC 2020-01-17 |