MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM— 510(k) K003575
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K003575 for MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM, Substantially Equivalent on 2001-01-17. Applicant: GE Medical Systems. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems
- Product code
- Code LNI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code LNI
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