Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

Q: What is the product code of K163624?

The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.

FDA 510(k) K163624 · Fujifilm Medical Systems U.S.A, Inc.

Substantially Equivalent

510(k) numberK163624

Submission

Device name: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Applicant: Fujifilm Medical Systems U.S.A, Inc.
Stamford, CT, US
Received: December 22, 2016
Decision date: June 30, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1680
Specialty: Radiology

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K242770	Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special	DRTECH Corporation	03/20/2025SE
K243443	Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special	DRTECH Corporation	03/19/2025SE
K243556	Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional	Iray Imaging Technology (Haining) Limited	03/18/2025SE

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Questions and answers

When was Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) cleared by the FDA?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (K163624) received a 510(k) decision of Substantially Equivalent on June 30, 2017, 190 days after the submission was received.

What is the product code of K163624?

The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.