# K232346: Digital Expert Access with Remote Scanning

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Oct 27, 2023 after 84 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: 16 generations back to K971684 (1997). 55 ancestors in all.
No later device cites it as a predicate yet.
5 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213668: SIGNA Hero, Ge Healthcare (Ge Medical Systems, LLC) (2022) Summary page 4.
- K150193: Customer Remote Console (CRC), Ge Medical Systems, LLC (2015) Summary page 4.
- K052423: Magnetom Systems with Syngo Expert - I Option, Siemens Medi Cal Solutions, Inc. (2006) Summary page 5.

## Indications for use
Digital Expert Access with Remote Scanning is a remote scan assistance solution which allows remote control of an MR Imaging Device including the ability to initiate a scan remotely. This access provides real time communication mechanisms between the remote and onsite users to facilitate the acquisition occurring on the device. Access must be granted by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.

Source page: https://510kreport.com/device/K232346
Methodology: https://510kreport.com/methodology