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Prostate Mechanical Imager

by Artann Laboratories, Inc.

De Novo DEN100016

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN100016 Date27 Apr 2012DecidedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
OQT
Device Class
Class II
Regulation
21 CFR Part 876.2050
Advisory Committee
Gastroenterology, Urology
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 19 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 Prostate Mechanical Imager is a Prostate Lesion Documentation System (FDA classification OQT, regulation 876.2050) designed to generate real-time three-dimensional images of the prostate gland. It functions by mechanically mapping the prostate’s surface and internal structure to identify and locate abnormalities, such as nodules, within the gland. This device aids in diagnostic assessment by providing visual data for further evaluation, including potential cancer screening.

The Prostate Mechanical Imager is used in urological and gastroenterological settings for diagnostic imaging of the prostate. Supplied as a reusable system, it requires sterile preparation for clinical use and is intended for use in non-MRI environments. The device is authorised under FDA 510(k) clearance (K-number DEN100016) and is classified as a Class II medical device. Storage and handling follow standard aseptic protocols to ensure device integrity and patient safety.

Questions

AI-generated answers, 19 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 clinical specialties primarily use the Prostate Mechanical Imager, and how does it assist in their diagnostic workflow?

    The Prostate Mechanical Imager is designed for use in urological and gastroenterological settings, where it aids in prostate imaging for diagnostic assessment. It generates real-time three-dimensional images of the prostate gland by mechanically mapping its surface and internal structure. This helps clinicians identify and locate abnormalities like nodules, which can be critical for further evaluation—particularly in cancer screening—by providing detailed visual data for review.

  • Is the Prostate Mechanical Imager intended for single-use or reusable applications, and what preparation is required before clinical use?

    The Prostate Mechanical Imager is supplied as a reusable system, meaning it is designed for multiple uses in clinical settings. However, before each use, it must undergo sterile preparation to ensure patient safety and device integrity, following standard aseptic protocols. This is standard for reusable medical devices used in diagnostic imaging.

  • What types of environments is this device intended for, and are there any restrictions on its use?

    The Prostate Mechanical Imager is explicitly designed for use in non-MRI environments, meaning it should not be operated in areas where magnetic resonance imaging is conducted. Its primary purpose is to provide real-time 3D imaging of the prostate in urological and gastroenterological settings, where MRI compatibility is not required.

  • How does the Prostate Mechanical Imager differ from traditional imaging methods for prostate assessment?

    Unlike traditional imaging techniques (such as ultrasound or MRI), the Prostate Mechanical Imager uses a mechanical mapping system to create detailed 3D visualizations of the prostate’s surface and internal structure in real time. This approach helps clinicians pinpoint abnormalities like nodules with greater precision, supporting more accurate diagnostic assessments—particularly for conditions like prostate cancer—by providing tactile and visual data integration.