Skip to content

RevealAI-Lung™

by Precision Medical Ventures Inc. United States EUDAMED510(k)GUDID

Ref SW-00001510(k) K251769 Product code POKEMDN Z11030582

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00860012425303 UDI-DIDate29 May 2026ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251769 Date30 Jan 2026ClearedStatusActive
European UnionCE/MDR EUDAMED NumberB-00860012425303 Basic UDI-DIDate9 Jul 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00860012425303 Basic UDI-DIDate9 Jul 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Generic Name
X-ray image interpretive software
Model / Ref / Catalog
SW-00001 EUDAMED
v1.x GUDID
Primary DI / UDI-DI
00860012425303
Basic UDI-DI
B-00860012425303, 08600124253SW-00001UB
Direct Marketing DI
00860012425303
510(k) Number
FDA Product Code
POK
EMDN Code
Z11030582 Radiology instruments - software accessories
GMDN Term
X-ray image interpretive software
Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.2060
Special Device Type
-1192
Software
Market of Registration
Netherlands
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
SW-00001
510(k)
n/a
GUDID
v1.x
Device ClassEUDAMED
Class IIa
Class IIb
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000039325
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED cd301a09-d906-48e9-8cd9-d5ad1f817075 61 fields · synced 22 Oct 2026
  • FDA 510(k) K251769 24 fields · synced 18 May 2026
  • EUDAMED 00860012425303|08600124253SW-00001UB 61 fields · synced 11 Jul 2026
  • FDA UDI fec87a09-82eb-4ca8-bd46-984441f3ba33 35 fields · synced 22 Oct 2026