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NUMARIS 4VA15A

by Siemens Medical Corp.

510(k) K012202

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 · Traditional NumberK012202 Date27 Sep 2001ClearedStatusActive

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  • Withdrawn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, 21 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 NUMARIS 4VA15A is a magnetic resonance diagnostic device (MRDD) used to produce cross-sectional images and spectra based on hydrogen-1 and phosphorus-31 metabolites. It functions as a software and hardware upgrade for Siemens MAGNETOM MRI systems, enabling the display of internal structure and function of the head, body, or extremities. The system is intended for use in radiology settings by trained physicians to assist in diagnosis.

The device is operated in clinical settings by trained physicians and is supplied as an upgrade for existing Siemens MRI systems. It is classified as a Class II device and is subject to regulatory oversight under FDA 510(k) procedures. The device was cleared under K-number K012202 in 2001 and is associated with product code LNH. It is designed for use in radiology and is listed under the advisory committee RA.

Other devices from Siemens Medical Corp.

Questions

AI-generated answers, 21 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 NUMARIS 4VA15A used for?

    It is a magnetic resonance diagnostic device (MRDD) designed to produce cross-sectional images and spectra based on hydrogen-1 and phosphorus-31 metabolites. It is used in radiology settings by trained physicians to assist in diagnosing conditions in the head, body, or extremities.

  • How is the NUMARIS 4VA15A supplied?

    It is supplied as a software and hardware upgrade for existing Siemens MAGNETOM MRI systems. It is not a standalone system but an enhancement to compatible Siemens MRI platforms.

  • Is the NUMARIS 4VA15A single-use or reusable?

    The device is intended for reuse in clinical settings. As a diagnostic upgrade, it is installed on MRI systems and used repeatedly for multiple patient scans over time.

  • What regulatory pathway did the NUMARIS 4VA15A follow?

    It was cleared under the FDA 510(k) process with K-number K012202 in 2001. The clearance was based on a determination of substantial equivalence to a predicate device, and it is classified as a Class II device under product code LNH.

  • What are the storage requirements for the NUMARIS 4VA15A?

    As a software and hardware upgrade for MRI systems, it does not have standalone storage requirements. It should be stored and operated in accordance with the host Siemens MAGNETOM system’s environmental specifications, typically in a controlled radiology setting.