# K133609: The Dome S6C

- Pathway: 510(k) (Special)
- Applicant: Nds Surgical Imaging
- Decided: Feb 28, 2014 after 95 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: 3 generations back to K001753 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032638: Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray, Planar Systems, Inc. (2003) Summary page 1.

## Indications for use
Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. Model Dome S6c is not intended for mammography use.

Source page: https://510kreport.com/device/K133609
Methodology: https://510kreport.com/methodology