# K093603: Storm-Base 2.0

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Mar 18, 2010 after 118 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K924178 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043324: Aida with Dicom and HL7 Interface, KARL STORZ Endoscopy-America, Inc. (2005) Summary page 2.

## Indications for use
StorM-Base 2.0 is intended to be used by physicians and other qualified medical personnel for the documentation, communication, display, printing and storage of medical diagnostic data in the field of Lithotripsy. When installed with a Storm-Touch system, it is also an image archiving system based on the DICOM standard capable of capturing and annotating lithotripsy procedures for documentation purposes. Images imported and distributed by StorM-Base 2.0 are for viewing and reference purposes only and are not intended for primary diagnosis.

Source page: https://510kreport.com/device/K093603
Methodology: https://510kreport.com/methodology