FDA.reportPublic FDA data

UNIDOS

Primary DI
EPTWTN100530
Brand
UNIDOS
Company
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Model
UNIDOS Romeo
Catalog number
TN10053
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951764000UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTORPtw-New York Corp.1995-10-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPTWTN100530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation electrometerA stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate.

Regulatory Flags#

DUNS number
318749751
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPTWS070031Q5200VERIQAVERIQA RT MonteCarlo 3D v3S070031.5202026-04-17
EPTWT20020Q1Q1000COUCHFIXCOUCHFIX Locating bar VarianT20020.1.1002026-04-16
EPTWT20020Q1Q1100COUCHFIXCOUCHFIX Locating bar ElektaT20020.1.1102026-04-16
EPTWT20020Q1Q1300COUCHFIXCOUCHFIX Locating bar MRIdianT20020.1.1302026-04-16
EPTWT20020Q1Q2000COUCHFIXCOUCHFIX RUBY PhantomT20020.1.2002026-04-16
EPTWT20020Q1Q3000COUCHFIXCOUCHFIX OCTAVIUS 4D PhantomT20020.1.3002026-04-16
EPTWT20020Q1Q3100COUCHFIXCOUCHFIX OCTAVIUS DetectorT20020.1.3102026-04-16
EPTWT20020Q1Q4000COUCHFIXCOUCHFIX QUICKCHECKT20020.1.4002026-04-16
EPTWT41018Q1Q0100MP1 Manual Water PhantomMP1 Reference Detector HolderT41018.1.0102026-04-16
EPTWT41018Q1Q0120MP1 Manual Water PhantomMP1 Plug HolderT 41018.1.0122026-04-16
EPTWT41019Q1Q0040MP1 Manual Water PhantomMP1 Detector Holder 7 mmT41019.1.0042026-04-16
EPTWT41019Q1Q0050MP1 Manual Water PhantomMP1 Detector Holder FarmerT41019.1.0052026-04-16
EPTWT41019Q1Q0060MP1 Manual Water PhantomMP1 Detector Holder Advanced MarkusT41019.1.0062026-04-16
EPTWT41019Q1Q0070MP1 Manual Water PhantomMP1 Detector Holder RoosT41019.1.0072026-04-16
EPTWT41019Q1Q0120MP1 Manual Water PhantomMP1 Detector Holder Bragg-Peak 10.5 cm³T41019.1.0122026-04-16
EPTWT410250MP1 Manual Water PhantomMP1 Manual Water PhantomT410252026-04-16
EPTWT410330MP1 Manual Water PhantomMP1 Manual Water Phantom, Extra LinesT410332026-04-16
EPTWT410520MP1 Manual Water PhantomMP1 Manual Water Phantom MRT410522026-04-16
EPTWS0700300PQASoftPQASoft 1.xS0700302026-04-15
EPTWT110620DIAMENTORDIAMENTOR RS-KDK, Version RS232T110622026-04-15

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