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Focus HD 35 Detector

by Iray Technology Taicang, Ltd.

510(k) K213646

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK213646 Date29 Mar 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQB
FDA applicant
Iray Technology Taicang , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Focus HD 35 Detector is a Solid State X-Ray Imager, also known as a Flat Panel or Digital Imager, used in the field of Radiology. It is designed to capture and process x-ray images. The device is classified as a Class 2 device.

The Focus HD 35 Detector is supplied with various registration numbers, including 3009717300, and is regulated under regulation number 892.1680. It has been cleared by the FDA under the 510K clearance type, with a decision code of SESE. The device is intended for use in a medical setting, specifically in the field of Radiology.

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