DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

Q: What is the product code of K161368?

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) K161368 · Agfa Healthcare N.V.

Substantially Equivalent

510(k) numberK161368

Submission

Device name: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
Applicant: Agfa Healthcare N.V.
Mortsel, BE
Received: May 17, 2016
Decision date: September 22, 2016
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

Other 510(k)s with product code MQB

510(k)	Device	Applicant	Decision
K253800	0909FCE, 0909FCE-HSMQB · Traditional	Rayence Co., Ltd.	07/31/2026SE
K260820	Vivix-S 4386W (FXRD-4386WA)MQB · Special	Vieworks Co., Ltd.	06/18/2026SE
K252996	Universal 1417PIMQB · Abbreviated	Konica Minolta Healthcare Americas, Inc.	06/12/2026SE
K252911	Lux HD 2530 detector (Lux HD 2530)MQB · Special	Iray Imaging Technology (Haining) Limited	10/09/2025SE
K250211	Yushan X-Ray Flat Panel DetectorMQB · Traditional	Innocare Optoelectronics Corp.	07/22/2025SE
K250665	SKR 3000MQB · Traditional	Konica Minolta, Inc.	06/17/2025SE
K243734	Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special	Allengers Medical Systems Limited	04/18/2025SE
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

More from Iray Imaging Technology (Haining) Limited

510(k)	Device	Decision
K252199	AGFA HealthCare Enterprise ImagingLLZ · Traditional	10/15/2025SE
K180589	DR 800 with MUSICA DynamicJAA · Traditional	04/05/2018SE
K172784	DX-D Imaging PackageMQB · Traditional	10/13/2017SE
K170434	Enterprise Imaging XERO Viewer 8.1LLZ · Traditional	07/03/2017SE
K161061	IMPAX Volume Viewing 4.0LLZ · Traditional	06/22/2016SE
K152639	DR 600MQB · Traditional	12/11/2015SE
K143397	ICIS ViewLLZ · Traditional	06/01/2015SE
K142316	IMPAX AgilityLLZ · Traditional	01/06/2015SE
K142184	Dx-D Imaging PackageMQB · Traditional	10/16/2014SE
K141602	Dx-D Imaging PackageMQB · Traditional	09/12/2014SE

Questions and answers

When was DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) cleared by the FDA?

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) (K161368) received a 510(k) decision of Substantially Equivalent on September 22, 2016, 128 days after the submission was received.

What is the product code of K161368?

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.