Chrysalis Intelligence · Product Codes · FET

FET · Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Gastroenterology, Urology · 19 clearances · 11 unique sponsors

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Device class

Class II

Regulation 876.1500

Total clearances

2020-05-01 → 2026-07-02

Last 12 months

Unique sponsors

Definition

What is Endoscopic Video Imaging System/Component, Gastroenterology-Urology

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.1500

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Olympus Medical Systems Corporation	5	1	2026-06-24
Richard Wolf Medical Instruments Corporation	3	0	2022-06-14
Fujifilm Corporation	3	1	2026-07-02
Olympus Corporations of the Americas	1	0	2025-04-02
Shenzhen Sophway Technology Co., Ltd.	1	0	2025-07-01
Univlabs Technologies Private Limited	1	0	2025-08-11
Proverum Limited	1	1	2025-09-24
Guangzhou Red Pine Medical Instrument Co., Ltd.	1	0	2025-02-07
Karl Storz Endoscopy America, Inc.	1	0	2022-05-13
Shanghai SeeGen Photoelectric Technology Co., Ltd.	1	0	2024-10-22
KARL STORZ Endoscopy-America, Inc.	1	0	2020-09-01

Reimbursement

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
43235	CPT	—	High	EGD procedure code covers use of endoscopic video imaging system
45398	CPT	—	High	Colonoscopy with video imaging system integrated
C1770	HCPCS	Imaging coil, magnetic resonance (insertable) ✓ CMS-verified description	Medium	Video imaging component may be billed separately as endoscopic component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-02	K261880	Fujifilm Corporation	FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
2026-06-24	K261260	Olympus Medical Systems Corporation	HD Camera Head OLYMPUS CH-S200-08-LB
2025-09-24	K251734	Proverum Limited	ProVee Video Processing Unit (PV-003)
2025-08-11	K250462	Univlabs Technologies Private Limited	UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
2025-07-01	K250204	Shenzhen Sophway Technology Co., Ltd.	Endoscopic Camera System
2025-04-11	K243260	Fujifilm Corporation	FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
2025-04-02	K242067	Olympus Corporations of the Americas	VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
2025-02-07	K243321	Guangzhou Red Pine Medical Instrument Co., Ltd.	Endoscopic Video Image Processor (RP-IPD-V1000F)
2024-10-22	K241532	Shanghai SeeGen Photoelectric Technology Co., Ltd.	Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
2024-07-03	K241371	Olympus Medical Systems Corporation	VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
2023-04-26	K222584	Olympus Medical Systems Corporation	EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
2022-06-14	K212808	Richard Wolf Medical Instruments Corporation	Logic Hd camera head green, System green
2022-05-13	K221174	Karl Storz Endoscopy America, Inc.	Telepack +
2021-10-01	K211332	Richard Wolf Medical Instruments Corporation	D Camera Controller
2020-10-29	K202646	Olympus Medical Systems Corp.	Visera Elite II Video System Center
2020-09-01	K201135	KARL STORZ Endoscopy-America, Inc.	Image1 S CCU, Image1 S 4U Camera Head
2020-07-22	K201200	Olympus Medical Systems Corp.	Visera Elite II Video System Center
2020-06-23	K200617	Richard Wolf Medical Instruments Corporation	Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
2020-05-01	K192286	Fujifilm Corporation	FUJIFILM EP-6000 Video Processor