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Standard Imaging QA BeamChecker Plus 90501

by Standard Imaging Inc.

Ref 90501

Standard Imaging QA BeamChecker Plus 90501 is an accelerator system quality assurance device (EU MDR Class I; FDA Class I; FDA product code LHO, Instrument, Quality-Assurance, Radiologic) made by Standard Imaging Inc., registered in EUDAMED on 16 May 2026 (Basic UDI-DI 0850019946QACHECKER94) with CE/MDR certificate 28620136130-01 valid until 18 Oct 2027 and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 00850019946116), active as of 8 Nov 2026.

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

18 Oct 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850019946QACHECKER94 Basic UDI-DI 00850019946116UDI-DIDate16 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850019946116 UDI-DI Date22 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850019946QACHECKER94 registered 16 May 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850019946116 listed 22 Jun 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620136130-01 Expiring Expires in 338 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    22 Feb 2023
    Expires
    18 Oct 2027

Timeline

4 dated events

  1. Certificate issued EUDAMED 28620136130-01
  2. Listed FDA GUDID 00850019946116
  3. Registered EUDAMED 0850019946QACHECKER94
  4. Certificate expires EUDAMED 28620136130-01

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
QA BeamChecker Plus EUDAMED
Standard Imaging QA BeamChecker Plus GUDID
Generic name
Accelerator system quality assurance device
Device name
QA Beam Analyzer
Model / Ref / Catalog
90501
Primary DI / UDI-DI
00850019946116
Basic UDI-DI
0850019946QACHECKER94
FDA product code
LHO
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Accelerator system quality assurance device
Device class
Class I
Regulation number
892.1940
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Accelerator system quality assurance device

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER.

Other devices from Standard Imaging Inc.

See all devices from Standard Imaging Inc. →

Properties

  • Measuring function
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)