WristView

FDA UDI

Class II (US FDA UDI)

by Aspect Imaging, Ltd.

Identity

Trade Name: WristView FDA UDI
Generic Name: Extremity MRI system, permanent magnet FDA UDI
Device Name: The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume is an ellipsoid with dimensions of 120mm X 120 mm X 70mm around the magnet center. The overall dimensions of the magnet assembly are 140 cm x 100 cm x 235 cm [with patient trolley]. FDA UDI
Model / Reference: WristView FDA UDI
Description: The Wrist\\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume is an ellipsoid with dimensions of 120mm X 120 mm X 70mm around the magnet center. The overall dimensions of the magnet assembly are 140 cm x 100 cm x 235 cm [with patient trolley]. FDA UDI

Identifiers

Catalog Number: 70006200 FDA UDI
Primary DI / UDI-DI: 00858755006101 FDA UDI
510(k) Number: K160185 FDA UDI
FDA Product Code: MOS FDA UDI
LNH FDA UDI
GMDN Term: Extremity 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

Yes

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

Yes

FDA UDI

Category: Extremity MRI system, permanent magnet

WristView by Aspect Imaging, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Aspect Imaging, Ltd.

Sources (1)

FDA UDI 003cf016-4ee7-45c5-9108-9a0194de8ec9 35 fields · synced Jun 8, 2026