ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)— 510(k) K083086
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K083086 for ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150), Substantially Equivalent on 2008-12-05. 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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