Biograph mMR with syngo MR E11P-AP01 system software— 510(k) K200213
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K200213 for Biograph mMR with syngo MR E11P-AP01 system software, Substantially Equivalent on 2020-05-11. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code OUO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code OUO
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view allRecalls naming K200213
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 K200213.
Data sourced from openFDA. This site is unofficial and independent of the FDA.