Fdr Acselerate System, Dr-Id 200 Flat Panel Detector

by Fujifilm Medical System U.S.A., Inc. 510(k)

Active United States

510(k) K093427

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK093427	Date21 Jan 2010Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K093427
FDA Product Code: MQB

Device Class: Class II
Regulation: 21 CFR Part 892.1680
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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