Dose Verification System Patient Dosimetry System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K080004 ↗

FDA Product Code

NZT

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Onedose Patient Dosimetry System

  Class II

  FDA 510(k) K040687 Active Cleared 25 Jun 2004

• Dose Verification System

  Class II

  FDA 510(k) K052118 Active Cleared 3 Apr 2006

• Modification to Onedose Patient Dosimetry System

  Class II

  FDA 510(k) K081859 Active Cleared 4 Aug 2008

• Dose Verification System Patient Dosimetry System, Model Dvs-I-11: Dvs Insertion Tool, Dvs-D-a: Dvs Dosimeter, Dvs-R-100

  Class II

  FDA 510(k) K071399 Active Cleared 20 Jun 2007

• Dose Verification System Patient Dosimetry System

  Class II

  FDA 510(k) K083035 Active Cleared 13 Nov 2008

• Dose Verification System Patient Dosimetry System, Models Dvs-I-11, Dvs Insertion Tool, Dvs-D-a, Dvs Dosimeter

  Class II

  FDA 510(k) K061051 Active Cleared 13 Jun 2006

• What is the Dose Verification System Patient Dosimetry System used for?

  This device is an implantable telemetric dosimeter specifically designed to measure ionizing radiation exposure in patients undergoing radiation therapy. It provides real-time verification of the radiation dose delivered to tissues and organs within or near irradiated areas, helping ensure accurate treatment planning and dose delivery in clinical settings.

• How is the Dose Verification System Patient Dosimetry System supplied and prepared for use?

  The system is supplied sterile and intended for single-use implantation only. It must be implanted by a healthcare professional following sterile medical device protocols. Proper handling and storage are critical to maintain its integrity and functionality before use.

• Is the Dose Verification System Patient Dosimetry System reusable or single-use?

  The device is explicitly designed for single-use implantation. After use, it should not be reused or reprocessed, as this could compromise its accuracy and sterility.

• Can the Dose Verification System Patient Dosimetry System be used in MRI environments?

  No, the device is explicitly noted as not MRI-safe. Patients with this implanted dosimeter should avoid MRI procedures to prevent potential interference or safety risks.

• What regulatory pathway does the Dose Verification System Patient Dosimetry System follow?

  The device is regulated under the FDA 510(k) clearance process (K080004) and classified as a Class II medical device under special controls. It falls under product code NZT and is intended for use in radiology settings.