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Detector Holder M9006300

by IBA Dosimetry GmbH

Detector Holder M9006300 (DA07-600) is a Class II device made by IBA Dosimetry GmbH, cleared under FDA 510(k) K032594 on 5 Sep 2003 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI EIBAM90063000), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K032594

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEIBAM90063000 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK032594 Date5 Sep 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032594 decided 5 Sep 2003 Active
  • FDA GUDID UDI-DI EIBAM90063000 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K032594
  2. Listed FDA GUDID EIBAM90063000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Detector Holder
Generic name
Accelerator system quality assurance device
Model / Ref / Catalog
M9006300, DA07-600
Primary DI / UDI-DI
EIBAM90063000
510(k) Number
FDA product code
IYE
GMDN term
Accelerator system quality assurance device
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

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Properties

Other properties (15, all answered No)