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 |