FDA.reportPublic FDA data

Cellvizio® 100 series (488nm)

Primary DI
03760187911007
Brand
Cellvizio® 100 series (488nm)
Company
MAUNA KEA TECHNOLOGIES
Model
210-0027
Catalog number
CS-100-488
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWNConfocal Optical Imaging

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111047000CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBESMauna Kea Technologies, Inc.2011-08-08OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760187911007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760187911007037601879110073760187911007

GMDN Terms#

Term, Definition table
TermDefinition
Confocal endomicroscopy systemAn assembly of mains electricity-powered (AC-powered) devices designed to visualize microscopic cellular and tissue structures during an endoscopic, interventional or surgical procedure to provide real-time images to facilitate further treatment planning. It is based on fluorescence confocal microscopy and typically consists of the confocal laser scanning unit, hand/foot controls, an endoscopic fibreoptic probe, and an image processing and display unit for visualization and/or recording.

Contacts#

Phone, Email table
PhoneEmail
+33170080967support@maunakeatech.com

Regulatory Flags#

DUNS number
394136118
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760187910055ColoFlex™ UHD211-0134MP-0006-HDC2016-09-24
03760187910079GastroFlex™ UHD211-0072MP-0009-HDG2016-09-24
03760187913001Cellvizio® I.V.E.FP-100012024-02-28
03760187910772AQ-Flex™ 19-C211-0211MP-0023-AQF2023-02-09
03760187912011AlveoFlex™ NFP-100292020-05-15
03760187912028GastroFlex™ NFP-100302020-05-15
03760187912035ColoFlex™ NFP-100312020-05-15
03760187912042CystoFlex™ R NFP-100322020-05-15
03760187912059AQ-Flex™ 19 NFP-100332020-05-15
03760187912073CholangioFlex™ NFP-100352020-05-15
03760187912080CelioFlex™ 5 NFP-100362020-05-15
03760187912097UroFlex™ NFP-100372020-05-15
03760187912103CystoFlex™ F NFP-100382020-05-15
03760187912004Cellvizio® I.V.E.FP-100012020-05-15
00827002472693Cellvizio® 100 series (488nm)210-0027CS-100-448-CK-12016-12-12
00827002472716Cellvizio® 100 series (488nm)210-0027CS-100-488-CK-32016-12-12
00827002472730UroFlex™B211-0142MP-0011-URF-CK2016-12-12
00827002472747CystoFlex™F211-0146MP-0012-CYS-CK2016-12-12
00827002472754CystoFlex™UHD R211-0147MP-0013-HCYS-CK2016-12-12
03760187910758CranioFlex™211-0174MP-0021-CRF2018-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403001ActivSight Light EngineActiv Surgical, Inc.OWN2026-05-26
00850016403018Activ Sight C-Mount Imaging ModuleActiv 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
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-11-21
06971679949782Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949799Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949805Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949812Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949829Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949836Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949843Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949850Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949867Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949874Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949881Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949898Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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
04048551418123n.a.Karl Storz GmbH & Co. KGOWN2025-08-11
04250480104200NASCHÖLLY FIBEROPTIC GmbHOWN2025-06-11
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17