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ProBeam Proton Therapy System - Rotating Gantry

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref ProBeam 4.3 MR6510(k) K133191

by Varian Medical Systems Particle Therapy GmbH & Co. KG

Identity

Trade Name
ProBeam Proton Therapy System - Rotating Gantry EUDAMEDFDA UDI
Generic Name
Proton therapy system FDA UDI
Device Name
ProBeam, ProBeam 360° EUDAMED
Model / Reference
ProBeam 4.3 MR6 EUDAMED
4.3 MR6 FDA UDI

Identifiers

Primary DI / UDI-DI
00858991006132 EUDAMEDFDA UDI
Basic UDI-DI
089947500200101PA EUDAMED
510(k) Number
K133191 FDA UDI
FDA Product Code
LHN FDA UDI
EMDN Code
Z11011001 PROTON THERAPY SYSTEMS EUDAMED
GMDN Term
Proton therapy system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

ProBeam Proton Therapy System - Rotating Gantry by Varian Medical Systems Particle Therapy GmbH & Co. KG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Varian Medical Systems Particle Therapy GmbH & Co. KG
EUDAMED SRN
DE-MF-000005626
FDA Applicant
Varian Medical Systems

Sources (3)

  • EUDAMED 6eee90a2-6a0a-4e8d-9dee-4159a1f31372 85 fields · synced Jun 18, 2026
  • FDA UDI 281eccf5-3cdb-4430-a992-6198119de1f6 33 fields · synced May 30, 2026
  • FDA 510(k) K133191 1 fields · synced May 18, 2026