GEHC DXA Bone Densitometers with enCORE version 18— 510(k) K191112
Substantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA 510(k) clearance K191112 for GEHC DXA Bone Densitometers with enCORE version 18, Substantially Equivalent on 2019-09-19. Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- 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
- Madison, WI, US
Recent devices under product code KGI
view allMore clearances from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
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 →
Recalls naming K191112
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191112.
Data sourced from openFDA. This site is unofficial and independent of the FDA.