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Therapax HT 150T

by Old Delft Corp. of America

510(k) K861431

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 NumberK861431 Date21 May 1986ClearedStatusActive

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  • Withdrawn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
JAD
Device Class
Class II
Regulation
21 CFR Part 892.5900
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Therapax HT 150T is a Class II X-ray system manufactured by Old Delft Corp. of America. It is a therapeutic X-ray system used in radiology applications. The device has a field strength of 150 T.

The Therapax HT 150T is supplied as a system and is regulated under FDA 510(k) clearance K861431 with product code JAD. It was cleared on May 21, 1986, and is manufactured by Old Delft Corp. of America in Fairfax, VA.

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Questions

AI-generated answers, 6 Oct 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 Therapax HT 150T used for?

    The Therapax HT 150T is a therapeutic X-ray system used in radiology applications. It has a field strength of 150 T and is designed for specific therapeutic procedures in medical settings.

  • How is the Therapax HT 150T supplied?

    The Therapax HT 150T is supplied as a complete system, including all necessary components for therapeutic X-ray procedures. It is manufactured by Old Delft Corp. of America in Fairfax, VA.

  • What is the regulatory status of the Therapax HT 150T?

    The Therapax HT 150T is regulated under FDA 510(k) clearance K861431 with product code JAD. It was cleared on May 21, 1986, and is classified as a Class II medical device.

  • Is the Therapax HT 150T a single-use device?

    The device data does not specify whether the Therapax HT 150T is designed for single-use or multiple uses. For specific usage instructions, please consult the manufacturer's documentation or contact Old Delft Corp. of America directly.