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S9 Display System

by O.M.I. Oncology Microsystems, Inc. 510(k)

Active United States

510(k) K874214

Overview

The S9 Display System is a therapeutic x-ray system, which includes signal analysis and display equipment. It is used to produce and control x-rays for radiation therapy. The system is classified as a Class II device. The device is associated with the medical specialty of radiology.

The S9 Display System is supplied with a product code of JAD and is regulated under 21 CFR 892.5900 and 892.5900. It has been issued an FDA 510(k) clearance, specifically K874214. The device is manufactured by O.M.I. Oncology Microsystems, Inc.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874214 Date22 Feb 1988ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JAD
Device Class
Class II
Regulation
21 CFR Part 892.5900
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from O.M.I. Oncology Microsystems, Inc.

  • DVS Option 01

    Class II

Questions

  • What is the S9 Display System used for?

    The S9 Display System is used to produce and control x-rays for radiation therapy, and is associated with the medical specialty of radiology.

  • Is the S9 Display System a single-use or reusable device?

    The device description does not specify whether the S9 Display System is single-use or reusable, but it is classified as a therapeutic x-ray system.

  • What regulatory clearance has the S9 Display System received?

    The S9 Display System has received an FDA 510(k) clearance, specifically K874214, indicating that it is substantially equivalent to a predicate device.

  • How is the S9 Display System supplied?

    The S9 Display System is supplied with a product code of JAD and is regulated under 21 CFR 892.5900.