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IORT System

by Northwest Medical Physics Center

510(k) K933117

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 · Traditional NumberK933117 Date16 Feb 1995ClearedStatusActive

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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
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 IORT System is a medical device classified as an Accelerator, Linear, Medical, used for intraoperative radiation therapy. It is designed to deliver radiation treatment directly to the tumor site during surgery, providing targeted therapy while minimizing exposure to surrounding healthy tissues.

The IORT System is supplied by Northwest Medical Physics Center and is FDA 510(k) cleared with device class 2. It is regulated under product code IYE and is intended for use in radiology procedures. The system includes various model numbers and registration numbers as specified in the device data.

Other devices from Northwest Medical Physics Center

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 IORT System used for?

    The IORT System is a medical device designed to deliver radiation treatment directly to the tumor site during surgery, providing targeted therapy while minimizing exposure to surrounding healthy tissues.

  • How is the IORT System supplied?

    The IORT System is supplied by Northwest Medical Physics Center and includes various model numbers and registration numbers as specified in the device data.

  • What is the regulatory status of the IORT System?

    The IORT System is FDA 510(k) cleared with device class 2, regulated under product code IYE, and intended for use in radiology procedures.

  • What are the specifications of the IORT System?

    The IORT System is classified as an Accelerator, Linear, Medical device with a decision description of Substantially Equivalent. It was reviewed by the Radiology advisory committee and received traditional clearance.