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Insight™

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref RT-4700-02Model Couchtops, Overlays, and Multipurpose Devices

by Qfix

Identity

Trade Name
Insight™ FDA UDI
Generic Name
Radiation therapy treatment planning positioning kit FDA UDI
Device Name
Insight™ MR Head Coil Holder FDA UDI
Model / Reference
RT-4700-02 EUDAMEDFDA UDI
Couchtops, Overlays, and Multipurpose Devices EUDAMED
Description
Insight™ MR Head Coil Holder FDA UDI

Identifiers

Catalog Number
RT-4700-02 FDA UDI
Primary DI / UDI-DI
10841962109946 EUDAMEDFDA UDI
Basic UDI-DI
8419621COUCHTOPSMPD6F EUDAMED
FDA Product Code
KXJ FDA UDI
EMDN Code
Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
GMDN Term
Radiation therapy treatment planning positioning kit FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1980 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Radiation therapy treatment planning positioning kit

Insight™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiation therapy treatment planning positioning kit.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qfix

Sources (2)

  • FDA UDI aa1c9334-082c-4015-8e9a-113b4574aafb 35 fields · synced Jun 20, 2026
  • EUDAMED ba177144-ad68-4636-b60f-e7b895c75d38 61 fields · synced Jun 20, 2026