The following data is part of a premarket notification filed by Quantitative Radiology Solutions, Llc with the FDA for Automatic Anatomy Recognition (aar).
Device ID | K203610 |
510k Number | K203610 |
Device Name: | Automatic Anatomy Recognition (AAR) |
Classification | Radiological Image Processing Software For Radiation Therapy |
Applicant | Quantitative Radiology Solutions, LLC 3675 Market Street, Suite 200 Philadelphia, PA 19104 |
Contact | Steve Owens |
Correspondent | Mary Vater Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
Product Code | QKB |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-10 |
Decision Date | 2021-04-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860006956004 | K203610 | 000 |