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Swoop Transmit and Receive Radio Frequency Head Coil
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 815-11016-06Model 850-11001-06 (900-11001-06, in crate)
Identity
- Trade Name
- Swoop Transmit and Receive Radio Frequency Head Coil EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Swoop® Portable MR Imaging® System EUDAMEDThe Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array. FDA UDITransmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.9) FDA UDI
- Model / Reference
- 850-11001-06 (900-11001-06, in crate) EUDAMED815-11016-06 EUDAMEDV2.0 (815-11016-04) FDA UDI900-11011-06 FDA UDI
- Description
- The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array. FDA UDITransmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.9) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850043319023 EUDAMEDFDA UDI00860000606158 FDA UDI
- Basic UDI-DI
- 0860000606100001R3 EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018002 MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Category: MRI system coil, radio-frequency
Swoop Transmit and Receive Radio Frequency Head Coil by Hyperfine Operations, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hyperfine Operations, Inc.
Sources (3)
- FDA UDI 7fd2e3b1-4b22-4123-b903-19404c698cf9 36 fields · synced Aug 4, 2026
- FDA UDI 76daee76-ae1b-472b-94e3-24dace67b41c 34 fields · synced May 30, 2026
- EUDAMED 2f8b47e0-db83-468e-bccd-a278799c0ba7 61 fields · synced Aug 4, 2026