Philips

FDA UDI

Class II (US FDA UDI)

by Shanghai Chenguang Medical Technologies Co., Ltd

Identity

Trade Name: Philips FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: Pediatr Body-Cardiac Coil 3T FDA UDI
Model / Reference: 4522-133-18721 FDA UDI
Description: Pediatr Body-Cardiac Coil 3T FDA UDI

Identifiers

Primary DI / UDI-DI: 06970564410178 FDA UDI
510(k) Number: K101949 FDA UDI
FDA Product Code: MOS FDA UDI
GMDN Term: MRI system coil, radio-frequency FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: MRI system coil, radio-frequency

Philips by Shanghai Chenguang Medical Technologies Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Operator's Manual Flexibility Siemens — NORAS MRI products GmbH · Class II
NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II

Cleared under the same submission

K101949 also covers:

Philips — Shanghai Chenguang Medical Technologies Co., Ltd

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shanghai Chenguang Medical Technologies Co., Ltd

Sources (1)

FDA UDI c18f5841-67c6-4e0a-9b94-59edaf8764cc 34 fields · synced Jun 8, 2026