Valory

Q: When was Valory cleared by the FDA?

Valory (K213469) received a 510(k) decision of Substantially Equivalent on November 18, 2021, 21 days after the submission was received.

Q: What is the product code of K213469?

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) K213469 · Agfa N.V.

Substantially Equivalent

510(k) numberK213469

Submission

Device name: Valory
Applicant: Agfa N.V.
Mortsel, BE
Received: October 28, 2021
Decision date: November 18, 2021
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

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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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Questions and answers

When was Valory cleared by the FDA?

Valory (K213469) received a 510(k) decision of Substantially Equivalent on November 18, 2021, 21 days after the submission was received.

What is the product code of K213469?

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.