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MAGNETOM Aera

by Siemens Medical Solutions USA, Inc. 3 variants

510(k) K190138

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 NumberK190138 Date15 Feb 2019ClearedStatusActive

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  • Withdrawn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, 23 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 Magnetom Aera is a Nuclear Magnetic Resonance Imaging system. It is classified as a Class II medical device.

The device received FDA 510(k) clearance (K190138) on February 15, 2019, and is substantially equivalent to a predicate device. It is manufactured by Siemens Medical Solutions USA, Inc. and is used in the radiology specialty.

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Questions

AI-generated answers, 23 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 Magnetom Aera used for?

    The Magnetom Aera is a Nuclear Magnetic Resonance Imaging system used in the radiology specialty to produce detailed internal body images for diagnostic purposes, based on its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • Who manufactures the Magnetom Aera and where is it located?

    The Magnetom Aera is manufactured by Siemens Medical Solutions USA, Inc., with its address listed as 40 Liberty Blvd., Mail Code 65-1a, Malvern, PA 19355, United States, as provided in the device authorization data.

  • What regulatory pathway was used for the Magnetom Aera and when was it cleared?

    The Magnetom Aera received FDA 510(k) clearance under submission K190138 on February 15, 2019, following a review that determined it to be substantially equivalent to a legally marketed predicate device.

  • What is the device classification and product code for the Magnetom Aera?

    The Magnetom Aera is classified as a Class II medical device with the product code LNH, which corresponds to Nuclear Magnetic Resonance Imaging systems under FDA regulation 892.1000.