Pediatric Body-Cardiac Coil, Model 5000012601
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Pediatric Body-Cardiac Coil EUDAMEDPhilips FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Pediatric Body-Cardiac Coil EUDAMEDPediatric Body-Cardiac COIL 1.5T FDA UDI
- Model / Reference
- 4522-150-41131 EUDAMEDFDA UDI
- Description
- Pediatric Body-Cardiac COIL 1.5T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970564410048 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970564410048 EUDAMED
- FDA Product Code
- MOS FDA 510(k)FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)FDA UDI
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Pediatric Body-Cardiac Coil, Model 5000012601, is a magnetic resonance specialty coil designed for imaging pediatric patients. It is intended for use in MRI systems to provide high-resolution images of the chest, heart, and surrounding structures in children, ensuring accurate diagnostic evaluation of cardiac and thoracic anatomy.
This coil is supplied as a single-use or reusable device, depending on manufacturer guidelines, and is intended for use in MRI-compatible environments. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. Proper storage and handling are required to maintain performance and sterility, adhering to the manufacturer’s instructions for use.
Frequently asked questions
What is the primary purpose of the Pediatric Body-Cardiac Coil, Model 5000012601, and which patients is it designed for?
The Pediatric Body-Cardiac Coil, Model 5000012601, is specifically designed for magnetic resonance imaging (MRI) to provide high-resolution images of the chest and heart in pediatric patients. It ensures accurate diagnostic evaluation of cardiac and thoracic anatomy, making it ideal for children rather than adults.
How should the Pediatric Body-Cardiac Coil be handled in terms of single-use versus reuse?
The coil can be used either as a single-use or reusable device, depending on the manufacturer’s guidelines. Proper storage and handling are required to maintain performance and sterility, so adherence to the manufacturer’s instructions is essential to ensure safe and effective use.
What regulatory approvals does the Pediatric Body-Cardiac Coil hold, and how does this affect its use?
The coil holds FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness. This approval allows it to be legally marketed and used in MRI systems for pediatric cardiac imaging, provided it is used within the intended scope as described by the manufacturer.
What storage requirements should be followed to maintain the coil’s performance and sterility?
The coil requires proper storage and handling to preserve its performance and sterility, as outlined in the manufacturer’s instructions. Since it can be used either as single-use or reusable, following these guidelines ensures the device remains functional and safe for use in MRI environments.
Is this coil compatible with all MRI systems, or are there specific system requirements?
The coil is designed for use in MRI systems but does not specify compatibility with all systems in the provided data. It is intended for MRI-compatible environments, so it should be used with systems that support specialty coils for pediatric cardiac imaging. Always verify compatibility with your specific MRI system before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101949 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Chenguang Medical Technologies Co., Ltd
- FDA Applicant
- Shanghai Chenguang Medical Technologies Co, Ltd.
Sources (3)
- FDA 510(k) K101949 24 fields · synced Oct 6, 2026
- FDA UDI 1ab22b26-8ce7-48ce-bdda-c2999ad7829d 34 fields · synced May 29, 2026
- EUDAMED 10abb497-e151-4ca0-bddd-345b2baeb5c1 61 fields · synced Jul 21, 2026