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Nomos Slit Collimator (Beak)

by Nomos Corp.

510(k) K974310

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 NumberK974310 Date6 Feb 1998ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Nomos Slit Collimator (Beak) is a medical device classified as a linear accelerator accessory used in radiosurgery and radiation therapy. It functions as a secondary collimator to further refine the width of a radiation beam after it has passed through an intensity-modulating collimator, ensuring precise targeting of treatment areas with slit widths ranging from 1 mm to 8 mm at isocenter.

This device is supplied as a reusable accessory for linear accelerators in radiology settings. It is intended for use in conjunction with other collimating systems and is regulated under FDA 510(k) clearance (K974310) with a classification of Class II (IYE). The device is designed for clinical environments where high-precision radiation delivery is required, adhering to regulatory standards for medical linear accelerators.

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