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ChestView

by Gleamer

Ref ChestViewModel BoneView / ChestView510(k) K241620

ChestView is a medical device (EU MDR Class IIa; FDA Class II; FDA product code MYN) made by Gleamer Sas, cleared under FDA 510(k) K241620 on 27 Feb 2025 and registered in EUDAMED on 17 Oct 2023 (Basic UDI-DI 377002083900003AJ), active as of 24 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241620↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241620 Date27 Feb 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number377002083900003AJ Basic UDI-DI 03770020839078UDI-DIDate17 Oct 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241620 decided 27 Feb 2025 Active
  • EUDAMED Basic UDI-DI 377002083900003AJ registered 17 Oct 2023 Active

Timeline

2 dated events

  1. Registered EUDAMED 377002083900003AJ
  2. Cleared FDA 510(k) K241620

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / reference
BoneView / ChestView, ChestView
Primary DI / UDI-DI
03770020839078
Basic UDI-DI
377002083900003AJ
510(k) Number
FDA product code
MYN
EMDN code
Z11039082 Various radiodiagnostic and interventional instruments - software accessories
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.2070
Special device type
Software
EU registration type
Standard device
EU market of registration
France
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIa
510(k)
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
FR-MF-000011358

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Gleamer Sas

See all devices from Gleamer Sas →

Properties

  • Measuring function
Other properties (13, all answered No)