# K001773: Orthone

- Pathway: 510(k) (Abbreviated)
- Applicant: Oni, Inc.
- Decided: Aug 18, 2000 after 67 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120701: M2 Wrist Mri System (2013), 20 descendants of its own
- K130692: M2 Wrist 2 Mri System (2014), 19 descendants of its own
- K160185: Wrist 3 (2016), 18 descendants of its own
- K170978: Embrace Neonatal MRI System (2017), 17 descendants of its own
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device (2020), 13 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0621-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Source page: https://510kreport.com/device/K001773
Methodology: https://510kreport.com/methodology