# K132831: Quiet/Silent Scanning Suite

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 1, 2013 after 52 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K971684 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 2.

## Indications for use
The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 systems Aera and Skyra with the updated software syngo MR D13A 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/K132831
Methodology: https://510kreport.com/methodology