ViZion DR + Wireless

Q: What is the product code of K160810?

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) K160810 · Viztek, LLC

Substantially Equivalent

510(k) numberK160810

Submission

Device name: ViZion DR + Wireless
Applicant: Viztek, LLC
Garner, NC, US
Received: March 24, 2016
Decision date: May 20, 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
K152279	ViZion DR + WirelessMQB · Special	09/10/2015SE
K142919	ExaLLZ · Special	12/16/2014SE
K133139	Vizion UltraMQB · Special	04/03/2014SE
K123644	Vizion + DRMQB · Special	01/11/2013SE
K112661	Vizion DRMQB · Special	10/20/2011SE
K102123	Vizion DRKPR · Traditional	01/24/2011SE
K091752	Viztek WLKPR · Traditional	11/12/2009SE
K082604	Viztek DR, Models: DR1000, DR3000, DR4000KPR · Traditional	11/21/2008SE
K063337	Opal-RadLLZ · Traditional	12/12/2006SE
K003607	Onyx-Rad Telemedicine PacsLLZ · Traditional	02/15/2001SE

Questions and answers

When was ViZion DR + Wireless cleared by the FDA?

ViZion DR + Wireless (K160810) received a 510(k) decision of Substantially Equivalent on May 20, 2016, 57 days after the submission was received.

What is the product code of K160810?

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.