FDA.reportPublic FDA data

INSPIRA

Primary DI
04961333255801
Brand
INSPIRA
Company
HOYA CORPORATION
Model
EPK-i8020c
Device description
PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 91108)
Published
2025-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
FDTDuodenoscope And Accessories, Flexible/Rigid
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
PEAEndoscope, accessories, image post-processing for color enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333255818Direct MarkingGS10
04961333255801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333255818049613332558184961333255818
04961333255801049613332558014961333255801

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-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.

Regulatory Flags#

DUNS number
691519705
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14
04961333248209PENTAXEC38-i10L2020-12-14
04961333248315PENTAXEG29-i102020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04961333246779PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246830PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246847PENTAXHOYA CORPORATIONFDS2025-04-04
04961333246939PENTAXHOYA CORPORATIONFDS2025-04-04
04961333251636PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333249183DEFINAHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONFDF2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONFDS2023-10-31
04961333252145PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252145PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONFDF2023-09-20