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Mrj 3300

by Paramed S.R.L.

510(k) K122034

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 NumberK122034 Date6 Dec 2012ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mrj 3300 is a Nuclear Magnetic Resonance Imaging System, classified as a Class II device. It is designed for complete Musculoskeletal imaging, including joints of the extremities and Spine imaging.

The Mrj 3300 is supplied with FDA 510(k) clearance, and is used in the field of Radiology. The system has a unique design allowing for small installation space, with minimal site preparation required.

Other devices from Paramed S.R.L.

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    Class II

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    Class II

  • Mropen

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See all devices from Paramed S.R.L. →

Questions

AI-generated answers, 6 Oct 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 MRJ 3300 used for?

    The MRJ 3300 is used for complete Musculoskeletal imaging, including joints of the extremities and Spine imaging in the field of Radiology.

  • Is the MRJ 3300 supplied with any regulatory clearance?

    Yes, the MRJ 3300 is supplied with FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.

  • What are the benefits of the MRJ 3300's design?

    The MRJ 3300 has a unique design allowing for small installation space, with minimal site preparation required, making it a practical choice for facilities with limited space.

  • What class of device is the MRJ 3300?

    The MRJ 3300 is classified as a Class II device, indicating a moderate level of risk and requiring special controls to ensure safety and effectiveness.