FDA.reportPublic FDA data

VIDEO PROCESSOR

Primary DI
04961333228928
Brand
VIDEO PROCESSOR
Company
PENTAX OF AMERICA, INC.
Model
EPK-1000-US
Device description
EPK-1000 VIDEO PROCESSOR (US NEW)
Published
2018-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934918000EPM-3300 VIDEO PROCESSORPentax Precision Instrument Corp.1994-02-07FET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333228928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333228928049613332289284961333228928

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitA mains electricity (AC-powered) device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410480269FUJIFILMFUJIFILM CORPORATIONFET2026-05-22
00840432200063CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
04049047788553GimmiGimmi GmbHFET2026-03-04
04049047788577GimmiGimmi GmbHFET2026-03-04
04049047788584GimmiGimmi GmbHFET2026-03-04
06971176282399EviewZhuhai Pusen Medical Technology Co, LtdFET2026-01-22
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FET2025-12-31
05391533810088ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
05391533810095ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.FET2025-11-21
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04961333255801INSPIRAHOYA CORPORATIONFET2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFET2025-06-20
04250480104200NASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONFET2025-05-31
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170445453OTV-S700 UPGRADE PACK 3DOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04048551432259NAKarl Storz GmbH & Co. KGFET2025-03-27
04049047788539GimmiGimmi GmbHFET2025-03-20
04049047788546GimmiGimmi GmbHFET2025-03-20
04049047788560GimmiGimmi GmbHFET2025-03-20
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FET2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FET2025-02-28