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Therpac Radiotherapy Treatment Planning System

by Pinecliff Assoc.

510(k) K930506

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 NumberK930506 Date29 Aug 1994ClearedStatusActive

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  • Withdrawn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, 21 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 Therpac Radiotherapy Treatment Planning System is a medical device used in radiation oncology for planning radiotherapy treatments. It is classified as a Class II device under FDA regulation number 892.5050 and is substantially equivalent to a legally marketed predicate device.

The system was cleared through the FDA 510(k) process under traditional clearance, with decision date August 29, 1994, and K-number K930506. It is manufactured by Pinecliff Assoc. and is intended for use in radiology settings as indicated by the advisory committee classification.

Questions

AI-generated answers, 21 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 Therpac Radiotherapy Treatment Planning System used for?

    The Therpac Radiotherapy Treatment Planning System is used in radiation oncology for planning radiotherapy treatments, as stated in its description. It supports clinicians in designing treatment plans by calculating radiation dose distributions, which is essential for delivering precise radiation therapy to patients.

  • How is the Therpac Radiotherapy Treatment Planning System supplied or made available to users?

    The system is manufactured by Pinecliff Assoc. and was cleared for marketing through the FDA 510(k) process under traditional clearance, with decision date August 29, 1994, and K-number K930506. It is supplied as a complete treatment planning system for use in radiology settings, based on its advisory committee classification and intended use.

  • Is the Therpac Radiotherapy Treatment Planning System a single-use or reusable device?

    The Therpac Radiotherapy Treatment Planning System is a reusable software-based medical device, as it is a treatment planning system designed for repeated use in clinical environments. There is no indication in the provided data that it is single-use; instead, it is classified as a Class II device under FDA regulation 892.5050, which typically applies to reusable systems used in radiotherapy planning.