# K132119: Magnetom Prisma, Magnetom Prisma Fit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 22, 2013 after 136 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K971684 (1997). 34 ancestors in all.
12 later devices descend from it; 1 cites it directly.
4 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123510: Magnetom Skyra, Siemens Medical Solutions USA, Inc. (2013) Summary page 2.
- K123938: Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for Magnetom Symphony a Tim System, Syn, Siemens Medical Solutions USA, Inc. (2013) Summary page 2.

## Most influential descendants
- K181371: uMR 790 (2018), 11 descendants of its own
- K191157: uMR 780, uMR 790 (2019), 10 descendants of its own
- K193200: uMR Omega (2020), 8 descendants of its own
- K220332: uMR Omega with uWS-MR-MRS (2022), 7 descendants of its own
- K230152: uMR Omega (2023), 6 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2659-2025: 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
- Jul 9, 2019 · Class II · Z-2345-2019: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.

## Indications for use
The MAGNETOM Prisms and MAGNETOM Prismafit systems are indicated for use assa magnetic resonance diagnostic device (MRDD) that produces transverse, sagitlal, 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. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Prisma and MAGNETOM Prismafit systems may also be used for imaging during interventionall procedures when performed with MR compatible devices such as in-room display and MR Safe biopsy needles.

Source page: https://510kreport.com/device/K132119
Methodology: https://510kreport.com/methodology