FDA.reportPublic FDA data

Activ Sight C-Mount Imaging Module

Primary DI
00850016403018
Brand
Activ Sight C-Mount Imaging Module
Company
Activ Surgical, Inc.
Model
AS-IM001
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWNConfocal Optical ImagingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016403018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016403018008500164030188500164030180850016403018

GMDN Terms#

Term, Definition table
TermDefinition
Laser speckle blood flowmeterAn electrically-powered device designed to use laser speckle imaging to measure micro- and macrovascular blood circulation and to assess the extent of vascular flow and associated changes [i.e., due to clots, stenosis, vascular tone changes, mechanical damage, and peripheral vascular disease (PVD)]. It uses laser light projected onto tissue and a multi-element light detector (e.g., a digital camera) to detect remitted light, thus enabling a measure of spatial variation (map) of blood flow. The device typically consists of one or more optical sensors connected to a software-controlled control/visual display unit.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
079855777
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016403001ActivSight Light EngineAS-LE0012026-05-26
00850016403025ActivSIght Light GuideAS-LC0012026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerAS-AD0012026-05-26
00850016403049ActivSight Imaging Module Clean and Disinfect TrayAS-IMT0022026-05-26
00850016403063ActivSight Light Cable Sterilization TrayAS-LCT0012026-05-26
00850016403070ActivSight Imaging Module Tray for VHPAS-IMT0012026-05-26
00850016403087ActivSight Light Cable Adapter - StorzAS-AD0022026-05-26
00850016403094ActivSight Integrated Imaging ModuleAS-IM0022026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRAS-AD0052026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRAS-AD0032026-05-26
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRAS-LAP5302026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRAS-LAP10302026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayAS-SCT0012026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRAS-LAP502026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRAS-LAP1002026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403001ActivSight Light EngineActiv Surgical, Inc.OWN2026-05-26
00850016403025ActivSIght Light GuideActiv Surgical, Inc.OWN2026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerActiv Surgical, Inc.OWN2026-05-26
00850016403087ActivSight Light Cable Adapter - StorzActiv Surgical, Inc.OWN2026-05-26
00850016403094ActivSight Integrated Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRActiv Surgical, Inc.OWN2026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRActiv Surgical, Inc.OWN2026-05-26
06971679949782Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949799Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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06971679949836Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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06971679949850Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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06971679949904Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949911Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949928Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949935Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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04048551418871NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551426166NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551426180NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551430569NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551436226NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551436233NAKarl Storz GmbH & Co. KGOWN2025-03-27