FDA.reportPublic FDA data

Image Processor

Primary DI
16970462546297
Brand
Image Processor
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
HUV-01
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231118000Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-11-13FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970462546297PackageGS11Not in Commercial Distribution
06970462546290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254629716970462546297
06970462546290069704625462906970462546290

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
403655303
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979988682000Single-Use UreterorenoscopeHU30S-V2026-07-25
06979988682017Single-Use UreterorenoscopeHU30M-V2026-07-25
06979988682024Single-Use UreterorenoscopeHU30SC-V2026-07-25
06979988682031Single-Use UreterorenoscopeHU30SC2026-07-25
06970462547334HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/082026-07-11
06970462547341HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/112026-07-11
06970462547358HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/082026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/112026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/082026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/112026-07-11
06970462547396HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/102026-07-11
06970462547402HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/162026-07-11
06970462546771Single-use Ureteral Access SheathY-10-502025-07-23
06970462546788Single-use Ureteral Access SheathY-11-402025-07-23
06970462546795Single-use Ureteral Access SheathY-11-502025-07-23
06970462546801Single-use Ureteral Access SheathY-12-402025-07-23
06970462546818Single-use Ureteral Access SheathY-12-502025-07-23
06970462547457Single-use Ureteral Access SheathY-08-362026-02-10
06970462547464Single-use Ureteral Access SheathY-08-402026-02-10
06970462547471Single-use Ureteral Access SheathY-08-452026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28