510(k) Report

Devices descending from K110480

13 later devices reach Pde Photodynamic Eye through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143474Artemis Hand Held Imaging SystemQuest Medical Imaging201501
+1K133719Pde-NeoHamamatsu Photonics K.K.201411—
+2K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+2K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+3K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+4K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+5K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+5K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+5K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+5K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—