WIRELESS DR IMAGING OPTION-WDR1— 510(k) K102615
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K102615 for WIRELESS DR IMAGING OPTION-WDR1, Substantially Equivalent on 2010-11-18. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code MQB
view allMore clearances from Ge Medical Systems, LLC
view allRecalls naming K102615
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 K102615.
Data sourced from openFDA. This site is unofficial and independent of the FDA.