# K020991: Syngo MR 2002B

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 13, 2002 after 78 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970852 (1997). 6 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970852: Magnetom Project 024 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K993731: Sonata Gradients/Magnetom Symphony System, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.
- K003192: Magnetic Concerto, Siemens Medical Solutions USA, Inc. (2000)
- K002179: Magnetom Allegra System, Siemens Medical Solutions USA, Inc. (2000)
- K013586: Magnetom Trio System, Siemens Medical Systems, Inc. (2001)

## Most influential descendants
- K102748: 31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3T (2011), 1 descendant of its own
- K042718: 13C/1H Occipital Headcoil for Magnetom Allegra (2004), 1 descendant of its own
- K213480: 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (2023), 0 descendants of its own
- K102348: 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual Turned Surface Coil 3T (2010), 0 descendants of its own
- K080820: Tem 3002G- HN Dual Tune Head Coil (2008), 0 descendants of its own

## Recalls of this device
- Oct 16, 2003 · Not classified · Z-0175-03: Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
- Feb 28, 2003 · Not classified · Z-1087-03: software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

## Indications for use
The MAGNETOM Systems with the syngo MR 2002B 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, 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/K020991
Methodology: https://510kreport.com/methodology