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Smart Fit TorsoCardiac 1.5T
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 989710012161510(k) K232021
Identity
- Trade Name
- Smart Fit TorsoCardiac 1.5T EUDAMED
- Device Name
- MR coils (Smart Fit Shoulder 1.5T/Smart Fit TorsoCardiac 1.5T) EUDAMED
- Model / Reference
- 989710012161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838111639 EUDAMED
- Basic UDI-DI
- 0884838BM1819N6 EUDAMED
- 510(k) Number
- K232021 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: MRI system coil, radio-frequency
Smart Fit TorsoCardiac 1.5T by Philips Healthcare (Suzhou) Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232021 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K260519 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM1819N6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000003923
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 9dbb3aab-3b5d-49a0-855f-848d8b49646b 61 fields · synced Jul 8, 2026
- FDA 510(k) K232021 24 fields · synced May 18, 2026