The following data is part of a premarket notification filed by Mindways Software, Inc. with the FDA for Ctxa Hip Extended Reference Data.
| Device ID | K030330 |
| 510k Number | K030330 |
| Device Name: | CTXA HIP EXTENDED REFERENCE DATA |
| 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 | 2003-01-31 |
| Decision Date | 2003-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B052DICTXAHIPEXTDB0 | K030330 | 000 |