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ChestView US 1.0.X

by Gleamer Sas

ChestView US 1.0.X is a radiological PACS-dedicated management software (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Gleamer Sas, cleared under FDA 510(k) K241620 on 27 Feb 2025 and listed in FDA GUDID since 2 Apr 2025 (UDI-DI 03770020839092), active as of 23 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 23 Oct 2026

Documents

510(k) K241620

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03770020839092 UDI-DI Date2 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK241620 Date27 Feb 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241620 decided 27 Feb 2025 Active
  • FDA GUDID UDI-DI 03770020839092 listed 2 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241620
  2. Listed FDA GUDID 03770020839092

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ChestView US
Generic name
Radiological PACS-dedicated management software
Model / reference
1.0.X
Primary DI / UDI-DI
03770020839092
510(k) Number
FDA product code
MYN
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2070
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Gleamer Sas

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Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)