Data / Medical devices / Germany / Rapid Biomedical GMBH
Rapid Biomedical GMBH: FDA-registered device maker in RIMPAR Bavaria, Germany, 6 510(k) clearances
Rapid Biomedical GMBH is registered with the FDA (registration 3005049692) in RIMPAR Bavaria, Germany. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005049692
- Address
- Kettelerstr. 3-11, RIMPAR Bavaria, Germany, 97222
- Owner or operator
- RAPID BIOMEDICAL GMBH (9070724)
- Roles
- Manufacturer
- First device listed
- December 5, 2008
- Registered through
- 2026
- Brand names listed
- 1.5 T 16Ch Diagnostic Breast Coil - P-H16LE-015-01811, 13C/1H Head Coil, 16 Ch AI Breast Coil 1.5 T, 16 Ch AI Breast Coil 3 T, 23Na 1Tx32Rx Head 7T, 23Na/1H Head Coil, 3 T 16Ch Diagnostic Breast Coil - P-H16LE-030-01630, 31P/1H Head Coil and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 1, 2023 | K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | MOS | Substantially Equivalent | Rapid Biomedical GmbH | accessdata.fda.gov |
| January 31, 2020 | K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | MOS | Substantially Equivalent | Rapid Biomedical GmbH | accessdata.fda.gov |
| February 15, 2019 | K183222 | MAGNETOM Terra | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 16, 2018 | K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | MOS | Substantially Equivalent | Rapid Biomedical GmbH | accessdata.fda.gov |
| March 21, 2018 | K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | MOS | Substantially Equivalent | Rapid Biomedical GmbH | accessdata.fda.gov |
| November 21, 2008 | K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T | MOS | Substantially Equivalent | Rapid Biomedical GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of Coil, Magnetic Resonance, Specialty
Updated February 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.