FDA.report

510(k) K241275

Device
Histolog® Scanner (Hardware 2.4, Software 3.3)
Applicant
Samantree Medical SA
510(k) number
K241275
Product code
OWN
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-19
Date received
2024-05-06
Regulation
876.1500
Classification name
Confocal Optical Imaging
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Olivier Delporte
Address
Ave. De Provence 12 Lausanne CH 1007 1007

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OWN

510(k)DeviceApplicantDecision date
K242163SmartSurgN Visualization SystemSmartsurgN, Inc.2026-04-20
K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG2026-02-26
K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.2026-02-13
K260108L12 LED Light Source with AIMStryker Endoscopy2026-02-12
K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG2026-02-12
K251336VISERA 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)Olympus Medical Systems Corp.2025-11-12
K243711Confocal 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);Wuxi Hisky Medical Technologies Co., Ltd.2025-07-24
K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC2025-02-19
K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG2023-11-21
K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG2023-11-06
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker2023-09-20
K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.2023-08-02
K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.2023-07-17
K230754L12 LED Light Source with AIMStryker2023-04-11
K213943SmartSurgN Visualization SystemSmartsurgn Incorporated2022-11-29