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Dornier MedTech UIMS

by Dornier MedTech GmbH 3 variants

Dornier MedTech UIMS (K1028986) is a device made by Dornier MedTech GmbH, approved under FDA PMA P840008 on 19 Dec 1984 and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 04049957000554), active as of 23 Oct 2026.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P840008

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 Number04049957000554 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP840008 Date19 Dec 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P840008 decided 19 Dec 1984 Active
  • FDA GUDID UDI-DI 04049957000554 listed 13 Sep 2018 Listed

Timeline

2 dated events

  1. Approved FDA PMA P840008
  2. Listed FDA GUDID 04049957000554

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Dornier MedTech
Generic name
Basic diagnostic x-ray system operation software
Model / Ref / Catalog
UIMS, K1028986
Primary DI / UDI-DI
04049957000554
PMA number
FDA product code
NSX
GMDN term
Basic diagnostic x-ray system operation software
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic diagnostic x-ray system operation software

Cleared under the same submission (P840008)

Other devices from Dornier MedTech GmbH

See all devices from Dornier MedTech GmbH →

Properties

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