FDA.reportPublic FDA data

Image Processor

Primary DI
06970462546290
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

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231118000
K231497000
K240374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231118000Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-11-13FAJ
K231497000Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-06FBN
K240374000Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-05-10FGB

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.

Regulatory Flags#

DUNS number
403655303
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06970462547488Single-use Ureteral Access SheathY-08-502026-02-10
06970462547495Single-use Ureteral Access SheathY-08-552026-02-10
06970462547501Single-use Ureteral Access SheathY-09-362026-02-10
06970462547518Single-use Ureteral Access SheathY-09-452026-02-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04055207007815NARichard Wolf GmbHFBN2026-05-29
04055207007839NARichard Wolf GmbHFBN2026-05-29
04055207008409NARichard Wolf GmbHFBN2026-05-29
04055207038505RIWORichard Wolf GmbHFBN2026-05-29
04055207038529RIWORichard Wolf GmbHFBN2026-05-29
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10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
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00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
08881300750107F88SG ENDOSCOPY PTE. LTD.FGB2025-06-30
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