FDA.reportPublic FDA data

N/A

Primary DI
04961333242467
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
92183/6
Device description
CABLE RGB TO EPK-1000
Published
2018-03-08
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
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122470000PENTAX EPK-I5010 VIDEO PROCESSORPentax Medical2013-04-10PEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333242467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333242467049613332424674961333242467

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Feet

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925153OPTIVISTAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925245DEFINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925450IMAGINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925696PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925849PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925856PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925894PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925900PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826927447PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25