ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL— 510(k) K081745
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K081745 for ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL, Substantially Equivalent on 2008-08-12. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Systems America, Inc.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
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