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FCT iStream Phase 2

by Fujifilm Corporation

510(k) K253836

FCT iStream Phase 2 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K253836 on 4 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 NumberK253836 Date4 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  • Withdrawn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
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K253836

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 K253836
UDI-DISize and differences
FCT iStream
FUJIFILM CORPORATION
FCT iStream / FCT iStream04573596204382 —On the market

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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