Dose Verification System Patient Dosimetry System

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K083035 ↗

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) K080004 Active Cleared 23 Jan 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 system is designed as an implantable telemetric dosimeter to measure and verify radiation doses delivered during therapy. It ensures accurate treatment planning and dose assessment in or near irradiated tissues or organs, helping clinicians confirm that the intended radiation dose is delivered precisely where needed.

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

  The device is supplied as a single-use implantable dosimeter. This design minimizes the risk of contamination or degradation between uses, ensuring consistent performance and reliability for each patient treatment session.

• Can this dosimeter be used with MRI machines?

  No, the Dose Verification System Patient Dosimetry System is explicitly not MRI-safe. Patients using this device should avoid MRI procedures, as the implanted dosimeter could interact with magnetic fields, posing safety risks.

• What regulatory approval does this device hold?

  The system holds FDA 510(k) clearance (K083035) under Special Controls for Class II medical devices, adhering to regulatory standards for ionizing radiation dosimetry. This classification ensures it meets stringent safety and performance requirements for use in radiation therapy.

• How should the Dose Verification System Patient Dosimetry System be stored?

  Proper storage is critical to maintain device integrity. The manufacturer specifies handling and storage guidelines to preserve sterility and functionality. Typically, single-use devices like this are stored in sealed, sterile packaging until immediate use, away from extreme temperatures or direct sunlight.