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NA UniSoft software, Edition 2000

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPTWS1000090 UDI-DI Date26 Apr 2017ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2439-2015 FDA Class II initiated 27 May 2015

    In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multi-modality therapeutic radiation phantom, anthropomorphic
Model / Ref / Catalog
UniSoft software, Edition 2000, S100009
Primary DI / UDI-DI
EPTWS1000090
510(k) Number
FDA Product Code
IYE
GMDN Term
Multi-modality therapeutic radiation phantom, anthropomorphic
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality therapeutic radiation phantom, anthropomorphic

Cleared under the same submission (K951764)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No