1.5T BC-10 Transmit/Receive MRI Coil

FDA UDI

Class II (US FDA UDI)

by Medspira Llc

Identity

Trade Name: 1.5T BC-10 Transmit/Receive MRI Coil FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: Medspira 1.5T BC-10 Transmit/Receive MRI Coil FDA UDI
Model / Reference: 42T9165 FDA UDI
Description: Medspira 1.5T BC-10 Transmit/Receive MRI Coil FDA UDI

Identifiers

Catalog Number: 42T9165 FDA UDI
Primary DI / UDI-DI: 00851607003013 FDA UDI
510(k) Number: K031119 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

Category: MRI system coil, radio-frequency

The Medspira 1.5T BC-10 Transmit/Receive MRI Coil is a high-performance, single-use coil designed for use in Magnetic Resonance Imaging (MRI) procedures. This advanced coil features a unique design that allows for enhanced image resolution and improved signal-to-noise ratio. With its compact size and lightweight construction, it is ideal for both clinical and research applications.

Similar devices

Also classified as MRI system coil, radio-frequency.

Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
All-Purpose Arch — NORAS MRI products GmbH · Class II
LEYLA Retractor Socket — NORAS MRI products GmbH · Class II
16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
All-Purpose Arch Adapter — NORAS MRI products GmbH · Class II
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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medspira Llc

Sources (1)

FDA UDI ef2a3b26-14be-4076-bf53-4a1c8dec3877 36 fields · synced Jul 24, 2026