510(k) Report

Devices descending from K071619

26 later devices reach Spy Fluorescent Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+1K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+1K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH20104—
+1K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.200820—
+2K231986Modus IRSynaptive Medical, Inc.20240—
+2K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.20230—
+2K214097Explorer Air IISurgvision GmbH20222—
+2K202391DIR 800Aesculap, Inc.20211—
+2K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+2K192761Asimov-MKS Imaging SystemOnlume, Inc.20200—
+2K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+2K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+2K110480Pde Photodynamic EyeHamamatsu Photonics K.K.201213—
+3K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20250—
+3K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+3K222240Explorer Air® IISurgvision GmbH20231—
+3K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+3K143474Artemis Hand Held Imaging SystemQuest Medical Imaging201501
+3K133719Pde-NeoHamamatsu Photonics K.K.201411—
+4K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+4K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+4K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+4K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+4K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+4K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+4K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—