16CH AI BREAST COILS 1.5 T AND 3 T— 510(k) K083255
Substantially EquivalentRapid Biomedical GmbH
FDA 510(k) clearance K083255 for 16CH AI BREAST COILS 1.5 T AND 3 T, Substantially Equivalent on 2008-11-21. 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
view all- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- 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
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.