VALORY

Solid State X-ray Imager (flat Panel/digital Imager)

Agfa N.V.

The following data is part of a premarket notification filed by Agfa N.v. with the FDA for Valory.

Pre-market Notification Details

• Device ID: K213469
• 510k Number: K213469
• Device Name: VALORY
• Classification: Solid State X-ray Imager (flat Panel/digital Imager)
• Applicant: Agfa N.V. Septestraat 27 Mortsel, BE B-2640
• Contact: Wim Govaerts
• Correspondent: Shaeann Cavanagh; Agfa US Corp. 10 South Academy Street Greenville, SC 29601
• Product Code: MQB
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-10-28
• Decision Date: 2021-11-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414904275535	K213469	000