EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
FDA 510(k) clearance K964307 · decided 1997-04-16
Clearance details
- K-number
- K964307
- Device name
- EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
- Applicant
- Lunar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-29
- Decision date
- 1997-04-16
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- KGI
- Device class
- 2
- Regulation number
- 892.1170
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| ABMD Software (K213760) | HeartLung Corporation | 2022-07-29 |
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| GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-12-02 |
| TBS iNsight (K152299) | Medimaps Group SA | 2016-04-29 |
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Recalls involving this device
No recalls on record reference this clearance.