1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support— 510(k) K191539
Substantially EquivalentRapid Biomedical GmbH
FDA 510(k) clearance K191539 for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support, Substantially Equivalent on 2020-01-31. 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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- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260947 — 0.55T 12Ch Breast Coil
- K252587 — HD 8Ch Wrist Array
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
More clearances from Rapid Biomedical GmbH
view all- K213480 — 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
- 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.