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Unidos E

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 3 variants

Unidos E (T10008) is a Class II device made by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, cleared under FDA 510(k) K951764 on 7 Oct 1995 and listed in FDA GUDID since 26 Apr 2017 (UDI-DI EPTWT100080), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K951764

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPTWT100080 UDI-DI Date26 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951764 Date7 Oct 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951764 decided 7 Oct 1995 Active
  • FDA GUDID UDI-DI EPTWT100080 listed 26 Apr 2017 Listed

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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K951764
  2. Recall initiated FDA recalls Z-2439-2015
  3. Listed FDA GUDID EPTWT100080

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Radiation electrometer
Model / Ref / Catalog
UNIDOS E, T10008
Primary DI / UDI-DI
EPTWT100080
510(k) Number
FDA product code
IYE
GMDN term
Radiation electrometer
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation electrometer

Cleared under the same submission (K951764)

and 8 more cleared under K951764

Similar devices in this category

Other devices filed under Radiation electrometer.

Other devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

See all devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)