The following data is part of a premarket notification filed by Mindways Software, Inc. with the FDA for Qct Pro Asynchronous Calibration Module, Cliniqct.
| Device ID | K140342 |
| 510k Number | K140342 |
| Device Name: | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT |
| Classification | Densitometer, Bone |
| Applicant | MINDWAYS SOFTWARE, INC. 3001 S Lamar Blvd Ste 302 Austin, TX 78704 |
| Contact | Keenan Brown |
| Correspondent | Keenan Brown MINDWAYS SOFTWARE, INC. 3001 S Lamar Blvd Ste 302 Austin, TX 78704 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-11 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B052DIASYNC0 | K140342 | 000 |