# K012202: Numaris 4VA15A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Corp.
- Decided: Sep 27, 2001 after 76 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: 1 generation back to K970852 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993731: Sonata Gradients/Magnetom Symphony System, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K970852: Magnetom Project 024 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K003192: Magnetic Concerto, Siemens Medical Solutions USA, Inc. (2000) Summary page 2.
- (no number) MAGNETOM Systems with Numaris 4VA12A: named in the summary without a submission number

## Indications for use
The MAGNETOM Systems with the Numaris 4 VA15A are indicated for use as magnetic resonance diagnostic devices (MRDD’s) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, based upon 'H and *'P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K012202
Methodology: https://510kreport.com/methodology