# K143253: O-MAR

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Apr 9, 2015 after 147 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: 4 generations back to K971055 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113394: Mavric SL, Ge Medical Systems, LLC (2012) Summary page 5.

## Indications for use
O-MAR is a combination of an acquisition technique and post-processing software intended for use on Achieva and Ingenia, 1.5T & 3T MR Systems. O-MAR is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition O-MAR is suitable for use on patients without implants that are cleared for MR exams. O-MAR helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus O-MAR improves visualization of more tissue in the vicinity of MR Conditional orthopedic implants. When interpreted by a trained physician, images generated by O-MAR provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K143253
Methodology: https://510kreport.com/methodology