The following data is part of a premarket notification filed by Mindways Software, Inc. with the FDA for Ctxa Hip; Ctxa; Qct Pro Ctxa Hip.
| Device ID | K002113 |
| 510k Number | K002113 |
| Device Name: | CTXA HIP; CTXA; QCT PRO CTXA HIP |
| Classification | Densitometer, Bone |
| Applicant | MINDWAYS SOFTWARE, INC. 282 SECOND ST., 4TH FL. San Francisco, CA 94105 -3130 |
| Contact | Christopher Cann |
| Correspondent | Christopher Cann MINDWAYS SOFTWARE, INC. 282 SECOND ST., 4TH FL. San Francisco, CA 94105 -3130 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-07 |
| Decision Date | 2001-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B052QCTPROM4ASH0 | K002113 | 000 |
| B052QCTPROM3SSH0 | K002113 | 000 |
| B052QCTPROM3ASH0 | K002113 | 000 |
| B052QCTPROM0SSH0 | K002113 | 000 |
| B052QCTPROM0SS0 | K002113 | 000 |
| B052QCTPROM0ASH0 | K002113 | 000 |
| B052QCTPROM0AS0 | K002113 | 000 |
| B052DICTXAHIP0 | K002113 | 000 |
| B052PHCTM40 | K002113 | 000 |