510(k) Report

Devices descending from K230727

4 later devices reach SPY Portable Handheld Imaging (SPY-PHI) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+1K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+1K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+1K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—