pixium 4343RCE

Q: When was pixium 4343RCE cleared by the FDA?

pixium 4343RCE (K170113) received a 510(k) decision of Substantially Equivalent on February 9, 2017, 28 days after the submission was received.

Q: What is the product code of K170113?

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) K170113 · Philips Medical Systems Dmc GmbH

Substantially Equivalent

510(k) numberK170113

Submission

Device name: pixium 4343RCE
Applicant: Philips Medical Systems Dmc GmbH
Hamburg, DE
Received: January 12, 2017
Decision date: February 9, 2017
Decision: Substantially Equivalent (SESE)
Type: Special 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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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

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K232910	CombiDiagnost R90JAA · Special	10/19/2023SE
K212186	Philips Radiology Smart AssistantKPR · Traditional	12/13/2021SE
K212837	ProxiDiagnost N90JAA · Special	09/21/2021SE
K210692	DigitalDiagnostKPR · Special	04/02/2021SE
K203087	CombiDiagnost R90JAA · Traditional	12/03/2020SE
K202564	DigitalDiagnost C90MQB · Special	09/30/2020SE
K182973	DigitalDiagnost C90MQB · Traditional	01/11/2019SE

Questions and answers

When was pixium 4343RCE cleared by the FDA?

pixium 4343RCE (K170113) received a 510(k) decision of Substantially Equivalent on February 9, 2017, 28 days after the submission was received.

What is the product code of K170113?

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.