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Thales 3d Mr Scanner

FDA UDI

Class II (US FDA UDI)

by L A P Gmbh Laser Applikationen

Identity

Trade Name
THALES 3D MR SCANNER FDA UDI
Generic Name
Multi-modality therapeutic radiation phantom, test object FDA UDI
Model / Reference
Carriage System 0,35T FDA UDI

Identifiers

Catalog Number
0016165-0001 FDA UDI
Primary DI / UDI-DI
04260590372369 FDA UDI
510(k) Number
K200907 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Multi-modality therapeutic radiation phantom, test object FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Multi-modality therapeutic radiation phantom, test object

Thales 3d Mr Scanner by L A P Gmbh Laser Applikationen — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality therapeutic radiation phantom, test object.

Cleared under the same submission

K200907 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
L A P Gmbh Laser Applikationen

Sources (1)

  • FDA UDI b3634011-0dd9-438b-8886-2379c0dba10e 34 fields · synced Jun 8, 2026