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# FDA Clears Spectralis Imaging Module
- URL: https://www.fdaweb.com/fda-clears-spectralis-imaging-module/
- Published: 2024-10-14T12:00:00.000Z
- Updated: 2026-09-14T14:43:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157977

FDA has cleared a Heidelberg Engineering 510(k) for its Spectralis Flex Module, which the company describes as a multimodal, diagnostic imaging-only platform designed for imaging the posterior segment of pediatric and adult patients in a supine position. “The Flex Module mounts the renowned Spectralis to a movable stand with an articulated adjustable arm, offering unprecedented flexibility that extends imaging capabilities to various positions and acquisition environments,” it says.

Heidelberg says the Flex Module offers various imaging-only modalities, including high-resolution OCT \[optical coherence tomography\], OCT angiography, fluorescein angiography, indocyanine green angiography, blue laser autofluorescence, multicolor, and both widefield and ultra-widefield imaging.