510(k) Report

Devices descending from K970605

125 later devices reach 3-CCD Digital Camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+8K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+8K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+8K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+8K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+8K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+8K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+8K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+8K222240Explorer Air® IISurgvision GmbH20231—
+8K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+8K221217SPY LaparoscopeStryker20221—
+8K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+8K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+8K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+8K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+9K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+9K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+9K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+9K252010SPY LaparoscopeStryker Endoscopy20250—
+9K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+9K230754L12 LED Light Source with AIMStryker20236—
+9K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+9K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+9K221611780 nm L11 LED Light Source with AIMStryker202210—
+10K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—