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YTTRO FILTER

by Yttro Corp.

510(k) K833779

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833779 Date5 Jun 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
IZW
Device Class
Class II
Regulation
21 CFR Part 892.1610
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 YTTRO FILTER is a collimator device for radiographic imaging. It is designed to automatically adjust and control the X-ray beam during radiographic procedures. This device helps to optimize image quality by shaping and limiting the X-ray beam to the appropriate area.

The YTTRO FILTER is supplied as a reusable device and is not specified as MRI safe. It is stored according to standard medical device protocols. The device has FDA 510K clearance with product code IZW and is classified as a Class II medical device for radiology applications.

Questions

AI-generated answers, 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.

  • What is the YTTRO FILTER used for?

    The YTTRO FILTER is a collimator device designed for radiographic imaging. It automatically adjusts and controls the X-ray beam during procedures, helping to optimize image quality by shaping and limiting the X-ray beam to the appropriate area.

  • Is the YTTRO FILTER a single-use or reusable device?

    The YTTRO FILTER is supplied as a reusable device. It is not specified as MRI safe and should be stored according to standard medical device protocols.

  • What is the regulatory status of the YTTRO FILTER?

    The YTTRO FILTER has FDA 510K clearance with product code IZW and is classified as a Class II medical device for radiology applications. It received clearance on June 5, 1984, with K number K833779.

  • How is the YTTRO FILTER supplied and stored?

    The YTTRO FILTER is supplied as a reusable device and should be stored according to standard medical device protocols. No specific storage conditions beyond standard medical device protocols are mentioned in the device data.