DigitalDiagnost C90

Q: What is the product code of K182973?

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) K182973 · Philips Medical Systems Dmc GmbH

Substantially Equivalent

510(k) numberK182973

Submission

Device name: DigitalDiagnost C90
Applicant: Philips Medical Systems Dmc GmbH
Hamburg, DE
Received: October 26, 2018
Decision date: January 11, 2019
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
K233662	Radiography 7300 CKPR · Traditional	06/13/2024SE
K233678	Radiography 7000 MIZL · Traditional	02/14/2024SE
K233945	ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special	01/11/2024SE
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
K173433	ProxiDiagnost N90OWB · Traditional	02/05/2018SE

Questions and answers

When was DigitalDiagnost C90 cleared by the FDA?

DigitalDiagnost C90 (K182973) received a 510(k) decision of Substantially Equivalent on January 11, 2019, 77 days after the submission was received.

What is the product code of K182973?

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.