The following data is part of a premarket notification filed by Qlarity Imaging with the FDA for Quantx Breast Mri Biopsy Guidance Plugin.
| Device ID | K191959 |
| 510k Number | K191959 |
| Device Name: | QuantX Breast MRI Biopsy Guidance Plugin |
| Classification | System, Image Processing, Radiological |
| Applicant | Qlarity Imaging 222 W Merchndise Mart Plaza Suite 1230 Chicago, IL 60654 |
| Contact | Robert Tomek |
| Correspondent | Robert Tomek Qlarity Imaging 222 W Merchndise Mart Plaza Suite 1230 Chicago, IL 60654 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2019-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B80721 | K191959 | 000 |