# K934889: Olympus Imagemanager System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus
- Decided: Jan 28, 1994 after 107 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 19, 2003 · Not classified · Z-0047-04: Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
- Mar 5, 2003 · Not classified · Z-1126-03: Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

Source page: https://510kreport.com/device/K934889
Methodology: https://510kreport.com/methodology