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Peacock System

by Nomos Corp.

510(k) K963258

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 NumberK963258 Date18 Nov 1996ClearedStatusActive

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  • Withdrawn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, 26 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 Peacock System is a linear accelerator used for intensity-modulating conformal radiation therapy. It is designed to automatically create and implement a plan for treating targets of various sizes and shapes in different anatomical locations.

The Peacock System is supplied as a medical device with FDA 510(k) authorization. It is classified as a Class 2 device with the product code IYE and regulation number 892.5050. The system is intended for use in radiology and is designed to perform as intended, as demonstrated by physics and clinical testing.

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Questions

AI-generated answers, 26 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 Peacock System used for?

    The Peacock System is used for intensity-modulating conformal radiation therapy, creating and implementing treatment plans for targets of various sizes and shapes in different anatomical locations.

  • What type of device is the Peacock System?

    The Peacock System is a Class 2 medical device, classified with the product code IYE and regulation number 892.5050.

  • Is the Peacock System supplied sterile?

    The device data does not specify if the Peacock System is supplied sterile, but it is intended for use in radiology and designed to perform as intended, as demonstrated by physics and clinical testing.

  • What is the regulatory status of the Peacock System?

    The Peacock System has FDA 510(k) authorization, indicating it is substantially equivalent to a predicate device.