510(k) Report

Devices descending from K200737

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+1K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+1K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+1K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+2K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+2K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+2K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+2K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—