# K113281: Mri Sytems

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Anke High-Tech Co., Ltd.
- Decided: May 17, 2012 after 192 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: 2 generations back to K073457 (2008). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091580: Pica Whole Body Mri System, Time Medical Limited (2009) Summary page 2.

## Most influential descendants
- K202518: Promaxo MRI System (2021), 1 descendant of its own
- K232361: Promaxo MRI System II (2023), 0 descendants of its own

## Indications for use
MRI SYSTEMS, including ASM-030P1l (OPENMARK 1ll), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse. sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K113281
Methodology: https://510kreport.com/methodology