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Dose Verification System

by Sicel Technologies, Inc.

510(k) K052118

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 NumberK052118 Date3 Apr 2006ClearedStatusActive

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  • Withdrawn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
LHN
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Dose Verification System is an implantable telemetric radiation sensor used to measure the amount of radiation delivered to tumor and/or healthy tissue during radiation therapy. It is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.

The device is supplied as a single-use system and is used by radiation oncologists, medical physicists, dosimetrists, and radiation therapists. It is regulated under FDA 510(k) clearance with product code LHN and is classified as a Class II medical device. The system includes various models including Dvs-i-11 and requires proper setup and use according to the operator's manual.

Other devices from Sicel Technologies, Inc.

Questions

AI-generated answers, 25 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 Dose Verification System used for?

    The Dose Verification System is an implantable telemetric radiation sensor designed to measure the amount of radiation delivered to tumor and/or healthy tissue during radiation therapy, helping verify treatment planning and radiation dose accuracy.

  • How is the Dose Verification System supplied?

    The device is supplied as a single-use system and is intended for use by radiation oncologists, medical physicists, dosimetrists, and radiation therapists, requiring proper setup and use according to the operator's manual.

  • What models are available in the Dose Verification System?

    The system includes various models including Dvs-i-11, each designed to provide accurate radiation dose measurements during therapy, with specific model details available in the operator's manual.

  • What is the regulatory classification of the Dose Verification System?

    The device is regulated under FDA 510(k) clearance with product code LHN and is classified as a Class II medical device, indicating it has moderate risk controls associated with its use.