# K974084: Getinge/Castle Optiview Series Surgical Light

- Pathway: 510(k) (Traditional)
- Applicant: Getinge/Castle, Inc.
- Decided: Mar 3, 1998 after 125 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) ALM Prismatic®, model 7001 and 9001 series: named in the summary without a submission number
- (no number) Amsco SQ240: named in the summary without a submission number
- (no number) Berchtold Chromophare®, model C-570, C-570/570 and C-570/570/570: named in the summary without a submission number
- (no number) ALM Illuminator Spotlight: named in the summary without a submission number
- (no number) Berchtold Chromophare C-300: named in the summary without a submission number

## Indications for use
The Getinge/Castle OptiView®Surgical Lights are to be used in the same, (general type and configuration), surgical operatory theatres, and out-patient surgery centers that currently employ various models of the referenced predicate devices.

Source page: https://510kreport.com/device/K974084
Methodology: https://510kreport.com/methodology