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3.0T Prostate Imaging System

by Medrad, Inc.

510(k) K051349

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 · Special NumberK051349 Date23 Jun 2005ClearedStatusActive

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  • Withdrawn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
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 3.0t Prostate Imaging System is a receive-only surface coil designed for high-resolution MRI and spectroscopy of the prostate gland and pelvic tissue. It functions as an accessory to Siemens 3.0t Trio MRI scanners.

The device is a Class 2 Radiology device with product code MOS, and is supplied as a single unit. It is intended for use in a clinical setting, and is regulated under the Special 510(k) pathway. The device has been assigned the regulation number 892.1000, and has been cleared by the FDA under the 510(k) premarket notification K051349.

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Questions

AI-generated answers, 24 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 3.0T Prostate Imaging System used for?

    The 3.0T Prostate Imaging System is used for high-resolution MRI and spectroscopy of the prostate gland and pelvic tissue, functioning as an accessory to Siemens 3.0t Trio MRI scanners.

  • Is the 3.0T Prostate Imaging System supplied as a single unit or multiple units?

    The 3.0T Prostate Imaging System is supplied as a single unit.

  • What regulatory pathway was used for the 3.0T Prostate Imaging System?

    The 3.0T Prostate Imaging System was regulated under the Special 510(k) pathway and has been cleared by the FDA under the 510(k) premarket notification K051349.