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511-00022

by Caption Health, Inc. United States EUDAMEDGUDID

Ref 511-00022Model Caption AI on vScan

Product code QJUEMDN Z11040182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08600035863VSCAISM Basic UDI-DIDate7 May 2024RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00860003586341 UDI-DIDate1 Apr 2024ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Caption AI (Caption Guidance + Caption Interpretation)
Generic Name
Ultrasound imaging system application software
Model / Reference
Caption AI on vScan EUDAMED
511-00022 EUDAMED
Alastor GUDID
Primary DI / UDI-DI
00860003586341
Basic UDI-DI
08600035863VSCAISM
FDA Product Code
QJU, QIH
EMDN Code
Z11040182 Ultrasound scanners - software accessories
GMDN Term
Ultrasound imaging system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2100, 892.2050
Special Device Type
Software
Market of Registration
Germany
Commercial Distribution
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Caption AI on vScan
511-00022
GUDID
Alastor
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000022891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Caption Health, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 2e159e22-a92f-4170-9e01-34aec3fb3dd8 61 fields · synced 24 Oct 2026
  • FDA UDI fc2b2f3c-085f-4c2c-9051-9ab2870a69a0 33 fields · synced 25 May 2026