510(k) K030330
K030330 is an FDA 510(k) premarket notification submitted by Mindways Software, Inc. for the device "CTXA HIP EXTENDED REFERENCE DATA". The FDA issued a decision of Substantially Equivalent on June 20, 2003. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Mindways Software, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2003
- Date Received
- January 31, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer, Bone
- Device Class
- Class II
- Regulation Number
- 892.1170
- Review Panel
- RA
- Submission Type