Dr-Er Verfsion of Canon X-Ray Digital Cameras

Q: What is the product code of K023586?

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) K023586 · Canon USA, Inc.

Substantially Equivalent

510(k) numberK023586

Submission

Device name: Dr-Er Verfsion of Canon X-Ray Digital Cameras
Applicant: Canon USA, Inc.
Lake Success, NY, US
Received: October 25, 2002
Decision date: November 5, 2002
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

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
K090623	Digital Radiography CXDI-40G CompactMQB · Traditional	03/24/2009SE
K033624	Pacs Software Solution 2003LLZ · Special	12/15/2003SE
K031633	Canon Inc., Digital Radiography, Model CXDI-40CMQB · Traditional	06/11/2003SE
K031629	Canon Non-Mydriatic Retinal Camera, Model Cr-DgiHKI · Traditional	06/06/2003SE
K023750	Cannon Digital Radiography Model CXDI-40GMQB · Traditional	11/22/2002SE
K003689	Canon X-Ray Digital Camera, Model CXDI-31IXK · Traditional	01/02/2002SE
K992606	Canon Laser Blood Flowmeter (CLBF) Model 100HLI · Traditional	06/21/2000SE
K992547	Canon X-Ray Digital Camera, Model CXDI-22MQB · Traditional	10/13/1999SE
K981556	Canon X-Ray Digital Camera CXDI-11MQB · Traditional	11/04/1998SE
K980246	Non-Mydriatic Retinal Camera, Model CR6-45NMHKI · Traditional	05/06/1998SE

Questions and answers

When was Dr-Er Verfsion of Canon X-Ray Digital Cameras cleared by the FDA?

Dr-Er Verfsion of Canon X-Ray Digital Cameras (K023586) received a 510(k) decision of Substantially Equivalent on November 5, 2002, 11 days after the submission was received.

What is the product code of K023586?

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.