OWN · Confocal Optical Imaging · Chrysalis Intelligence

Sponsor	Clearances	Last 12 mo	Most recent
Mauna Kea Technologies	4	0	2022-04-11
Karl Storz SE & CO. KG	4	2	2026-02-26
Stryker	3	0	2023-09-20
Visionsense, Ltd.	2	0	2022-10-28
Activ Surgical, Inc.	2	0	2023-08-02
Novadaq Technologies Ulc. (Now A Part of Stryker)	2	0	2020-11-05
Olympus Medical Systems Corp.	2	1	2025-11-12
LIMIS Development B.V.	1	1	2026-07-24
Karl Storz Endoscopy America	1	0	2021-11-15
SmartsurgN, Inc.	1	1	2026-04-20
Wuxi Hisky Medical Technologies Co., Ltd.	1	0	2025-07-24
Karl Storz Endoscopy_America, Inc.	1	0	2020-12-17
Karl Storz-Endoscopy-America, Inc.	1	0	2020-08-17
Guangdong Optomedic Technologies, Inc.	1	0	2023-07-17
VPIX Medical, Inc.	1	1	2026-02-13
Stryker Endoscopy	1	1	2026-02-12
Smartsurgn Incorporated	1	0	2022-11-29
Optosurgical, LLC	1	0	2025-02-19
Samantree Medical SA	1	0	2024-08-19

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
43198	CPT	—	Medium	Esophageal ultrasound (EUS) including collection of specimen(s) by brushing or biopsy
52007	CPT	—	Medium	Cystourethroscopy, with collection of specimens by brushing of urothelial and bladder wall

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-24	K254180	LIMIS Development B.V.	PerfusiX-Imaging
2026-04-20	K242163	SmartsurgN, Inc.	SmartSurgN Visualization System
2026-02-26	K254242	Karl Storz SE & CO. KG	KARL STORZ ICG Imaging System with RUBINA® Lens
2026-02-13	K251852	VPIX Medical, Inc.	cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
2026-02-12	K260108	Stryker Endoscopy	L12 LED Light Source with AIM
2026-02-12	K253972	Karl Storz SE & CO. KG	IMAGE1 (TC400US); X-to-4U Adapter (TC040)
2025-11-12	K251336	Olympus Medical Systems Corp.	VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
2025-07-24	K243711	Wuxi Hisky Medical Technologies Co., Ltd.	Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
2025-02-19	K243591	Optosurgical, LLC	OPTOVISION Endoscopic Light Source Unit
2024-08-19	K241275	Samantree Medical SA	Histolog® Scanner (Hardware 2.4, Software 3.3)
2023-11-21	K233333	Karl Storz SE & CO. KG	KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
2023-11-06	K232857	Karl Storz SE & CO. KG	KARL STORZ ICG Imaging System
2023-09-20	K231854	Stryker	1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
2023-08-02	K231344	Activ Surgical, Inc.	ActivSight Intraoperative Imaging System
2023-07-17	K230407	Guangdong Optomedic Technologies, Inc.	FloNavi Open Field Fluorescence Imaging System
2023-04-11	K230754	Stryker	L12 LED Light Source with AIM
2022-11-29	K213943	Smartsurgn Incorporated	SmartSurgN Visualization System
2022-10-28	K223020	Visionsense, Ltd.	VS3-Iridium System (VS3-IR)
2022-06-29	K221611	Stryker	780 nm L11 LED Light Source with AIM
2022-04-11	K220477	Mauna Kea Technologies	Cellvizio 100 series system with confocal Miniprobes
2021-11-22	K210265	Visionsense, Ltd.	VS3 Iridium Sytem
2021-11-15	K212695	Karl Storz Endoscopy America	KARL STORZ ICG Imaging System
2021-08-18	K212322	Mauna Kea Technologies	Cellvizio I.V.E. system with Confocal Miniprobes
2021-04-08	K203550	Activ Surgical, Inc.	ActivSight Intraoperative Imaging System
2020-12-17	K202925	Karl Storz Endoscopy_America, Inc.	KARL STORZ ICG Imaging System

OWN · Confocal Optical Imaging

What is Confocal Optical Imaging

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances