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Multitom Rax

by Siemens Medical Solutions USA, Inc.

510(k) K152928

Multitom Rax is a medical device (FDA Class II; FDA product code OWB, Interventional Fluoroscopic X-Ray System) made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K152928 on 13 Nov 2015, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152928 Date13 Nov 2015ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1685-2021 FDA Class II initiated 20 Apr 2021

    Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.

Timeline

2 dated events

  1. Cleared FDA 510(k) K152928
  2. Recall initiated FDA recalls Z-1685-2021

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  • Withdrawn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
OWB
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K152928

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K152928
UDI-DISize and differences
Multitom Rax 10860700
Siemens Healthcare GmbH
10860700 / 1086070004056869009179 —On the market

Similar devices

Other devices filed under FDA product code OWB (Interventional Fluoroscopic X-Ray System).

Other devices from Siemens Medical Solutions USA, Inc.

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