31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil— 510(k) K213480
Substantially EquivalentRapid Biomedical GmbH
FDA 510(k) clearance K213480 for 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil, Substantially Equivalent on 2023-02-01. Applicant: Rapid Biomedical GmbH. Device class: 2.
Clearance details
- Applicant
- Rapid Biomedical GmbH
- 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
- Rimpar, DE
Recent devices under product code MOS
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- K260947 — 0.55T 12Ch Breast Coil
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More clearances from Rapid Biomedical GmbH
view all- K191539 — 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
- K181948 — 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
- K163661 — P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
- K102748 — 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
- K102348 — 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T
Data sourced from openFDA. This site is unofficial and independent of the FDA.