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Lunit INSIGHT CXR

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 113012Ref 113212510(k) K211733

by Lunit Inc.

Identity

Trade Name
Lunit INSIGHT CXR EUDAMED
Device Name
Lunit INSIGHT CXR EUDAMED
Model / Reference
113012 EUDAMED
113212 EUDAMED

Identifiers

Primary DI / UDI-DI
08800076000100 EUDAMED
08800076000209 EUDAMED
Basic UDI-DI
88000760CXRXN EUDAMED
510(k) Number
K211733 FDA 510(k)
FDA Product Code
QFM FDA 510(k)
EMDN Code
Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2080 FDA 510(k)
Regulation Number
892.2080 FDA 510(k)
Special Device Type
Software EUDAMED
Market of Registration
Poland EUDAMED
Belgium EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Lunit INSIGHT CXR by Lunit Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Lunit Inc.
EUDAMED SRN
KR-MF-000005200
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (3)

  • EUDAMED 10cbd146-8efc-47e2-b6a2-bf83524c6569 61 fields · synced Jul 12, 2026
  • EUDAMED 73e3cdc5-70e8-4a2e-951d-fb5f494a4854 61 fields · synced May 17, 2026
  • FDA 510(k) K211733 24 fields · synced May 18, 2026