The following data is part of a premarket notification filed by Aiq Solutions, Inc. with the FDA for Quantitative Total Extensible Imaging (qtxi).
| Device ID | K173444 |
| 510k Number | K173444 |
| Device Name: | Quantitative Total Extensible Imaging (QTxI) |
| Classification | System, Image Processing, Radiological |
| Applicant | AIQ Solutions, Inc. 8025 Excelsior Drive Madison, WI 53717 |
| Contact | Dona Alberti |
| Correspondent | Mitch Lewandowski EpiReg LLC 3428 John Muir Drive Middleton, WI 53562 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-06 |
| Decision Date | 2018-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007104909 | K173444 | 000 |