# K072237: Magnetom Verio

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 10, 2007 after 58 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971684 (1997). 9 ancestors in all.
300 later devices descend from it; 9 cite it directly.
22 of 310 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050200: Magnetom Trio a Tim System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.
- K062454: Magnetom Systems - I-Class and T-Class Releases, Siemens Medi Cal Solutions, Inc. (2006) Summary page 2.

## Most influential descendants
- K082427: Syngo MR B17 (2008), 229 descendants of its own
- K101347: Magnetom Aera; Magnetom Skyra (2010), 224 descendants of its own
- K103275: Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems (2011), 221 descendants of its own
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2664-2025: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, l
- Sep 12, 2012 · Class II · Z-2464-2012: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with resp
- Mar 26, 2012 · Not classified · Z-1364-2012: During product monitoring, Siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. The cable connections overheated, leading t
- Jan 10, 2011 · Not classified · Z-1401-2011: On some systems the gradient cable connections did not meet firm's specifications after installation

## Indications for use
The MAGNETOM Verio is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Verio may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.

Source page: https://510kreport.com/device/K072237
Methodology: https://510kreport.com/methodology