XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46— 510(k) K992125
Substantially EquivalentNorland Medical Systems, Inc.
FDA 510(k) clearance K992125 for XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46, Substantially Equivalent on 1999-11-22. Applicant: Norland Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Norland Medical Systems, Inc.
- Product code
- Code KGI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1170
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Atkinson, WI, US
Recent devices under product code KGI
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view allAdverse events under product code KGI
product code KGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.