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Quantib Prostate 3.2

by Quantib BV Netherlands EUDAMED510(k)GUDID

Ref 004-320Model QPR

Product code LLZEMDN Z119082

Overview

The Quantib Prostate 3.2 is a magnetic resonance imaging (MRI)-compatible measuring device (Nomenclature Code: Z119082) designed for quantitative assessment of prostate tissue. It provides precise volumetric and functional measurements, aiding in the evaluation of prostate conditions such as benign prostatic hyperplasia (BPH) or prostate cancer.

This non-sterile, single-use device (Model QPR, Reference 004-320) is intended for use in MRI environments and is classified as Class IIb under regulatory frameworks. Supplied as a ready-to-use kit, it requires no reprocessing and includes a unique Basic UDI (8719689791QPR1RH) for traceability. Authorized under FDA 510K and MDR compliance, it is distributed with clear storage instructions to maintain integrity prior to clinical application.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08719689791278 UDI-DIDate14 Dec 2023ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK230772 Date17 Apr 2023IssuedStatusActive
European UnionCE/MDR EUDAMED Number8719689791QPR1RH Basic UDI-DIDate6 Dec 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
Quantib Prostate 3.2 EUDAMED
Quantib Prostate GUDID
Generic Name
Radiology DICOM image processing application software
Model / Reference
QPR EUDAMED
004-320 EUDAMED
3.2 GUDID
Primary DI / UDI-DI
08719689791278
Basic UDI-DI
8719689791QPR1RH
Direct Marketing DI
08719689791278
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z119082 Various bioimaging and radiotherapy instruments - software accessories
GMDN Term
Radiology DICOM image processing application software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
QPR
004-320
GUDID
3.2
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000027601

Other devices from Quantib BV

See all devices from Quantib BV →

Questions

  • What is the Quantib Prostate 3.2 used for in clinical practice?

    The Quantib Prostate 3.2 is designed for quantitative assessment of prostate tissue during MRI scans. It provides precise volumetric and functional measurements, which help clinicians evaluate conditions like benign prostatic hyperplasia (BPH) or prostate cancer by improving diagnostic accuracy through detailed tissue analysis.

  • Is the Quantib Prostate 3.2 reusable or single-use, and how should it be handled?

    The Quantib Prostate 3.2 is a single-use device and must not be reprocessed or reused. It comes as a ready-to-use kit, so no additional preparation is required before clinical application. Since it is non-sterile, it should be handled in accordance with standard infection control practices to maintain its integrity prior to use.

  • What storage instructions should be followed for the Quantib Prostate 3.2?

    The device includes clear storage instructions to preserve its integrity before clinical use. While the exact details are not specified, it is generally recommended to store it in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use, as per the manufacturer’s guidelines.

  • How can I verify the authenticity and traceability of the Quantib Prostate 3.2?

    Each Quantib Prostate 3.2 kit includes a unique Basic UDI (8719689791QPR1RH) for traceability. This identifier allows for verification of the device’s authenticity and ensures compliance with regulatory requirements. The UDI also supports inventory management and recall tracking if needed.

  • What regulatory pathways does the Quantib Prostate 3.2 follow, and how does that affect its use?

    The device is authorized under both FDA 510K and MDR (Medical Device Regulation) compliance, meaning it meets the necessary safety and performance standards for use in the U.S. and EU markets. This regulatory clearance ensures its suitability for clinical use in MRI environments, though clinicians should always follow local guidelines and institutional protocols for implementation.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED c221bd07-ca53-44ef-98c9-4776b0cc2376 61 fields · synced 24 Oct 2026
  • FDA UDI a4e38e7d-017a-41bd-ac33-389e003c127d 34 fields · synced 30 May 2026
  • FDA 510(k) K202501 1 fields · synced 18 May 2026