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ChestView US (1.1)

by Gleamer

510(k) K252486

ChestView US (1.1) is a medical device (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Gleamer, cleared under FDA 510(k) K252486 on 9 Sep 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252486 Date9 Sep 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MYN
Device class
Class II
Regulation
21 CFR Part 892.2070
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K252486

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K252486
UDI-DISize and differences
ChestView US 1.1.X
Gleamer Sas
1.1.X03770020839153 —On the market

Similar devices

Other devices filed under FDA product code MYN (Analyzer, Medical Image).

Other devices from Gleamer