Body Spine Array L MR Coil Kit

FDA UDI

Class II (US FDA UDI)

by Siemens Shenzhen Magnetic Resonance Ltd.

Identity

Trade Name: Body Spine Array L MR Coil Kit FDA UDI
Generic Name: Full-body MRI system, permanent magnet FDA UDI
Device Name: Contains Medical Device Mat. 8635521 (GTIN:04056869039169) FDA UDI
Model / Reference: 10019289 FDA UDI
Description: Contains Medical Device Mat. 8635521 (GTIN:04056869039169) FDA UDI

Identifiers

Primary DI / UDI-DI: 04056869042299 FDA UDI
510(k) Number: K041111 FDA UDI
K043030 FDA UDI
K082331 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: Full-body MRI system, permanent magnet 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

Category: Full-body MRI system, permanent magnet

Body Spine Array L MR Coil Kit by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full-body MRI system, permanent magnet.

Promaxo MRI System — Promaxo, Inc. · Class II
ANKE — Shenzhen Anke High-Tech Co., Ltd. · Class II
PICA Whole-body MRI System — Time Medical Systems, Inc. · Class II
Promaxo MRI System — Promaxo, Inc. · Class II
Extremity L MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Breast coil c035 — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Body Spine Array M MR Coil Kit — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
Extremity Array Coil S — Siemens Shenzhen Magnetic Resonance Ltd. · Class II

Cleared under the same submission

K041111 also covers:

K043030 also covers:

K082331 also covers:

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: Siemens Shenzhen Magnetic Resonance Ltd.

Sources (1)

FDA UDI 92ce03da-2b97-4fcc-9921-fef5f4b01445 35 fields · synced May 30, 2026