FDA.reportPublic FDA data

Image Processor

Primary DI
06970462546207
Brand
Image Processor
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
HUV-02
Published
2024-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)
EOQBronchoscope (Flexible Or Rigid)
FAJCystoscope And Accessories, Flexible/Rigid
FBNCholedochoscope And Accessories, Flexible/Rigid
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
FGBUreteroscope And Accessories, Flexible/Rigid
KQMCamera, Surgical And Accessories
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1
NTNLed Light SourceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222910000
K231118000
K231497000
K232435000
K240374000
K241444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222910000Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-04-11EOQ
K231118000Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-11-13FAJ
K231497000Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-06FBN
K232435000Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-04-26EOB
K240374000Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-05-10FGB
K241444000Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2025-01-21FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970462546204PackageGS11Not in Commercial Distribution
06970462546207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254620416970462546204
06970462546207069704625462076970462546207

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
06970462546719Broncho SamplerBS012026-02-10
06970462546856Stone Collector180ML-L2026-02-10
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
06970462547525Single-use Ureteral Access SheathY-09-552026-02-10
06970462547532Single-use Ureteral Access SheathY-10-362026-02-10
06970462547549Single-use Ureteral Access SheathY-10-452026-02-10
06970462547556Single-use Ureteral Access SheathY-10-552026-02-10
06970462547563Single-use Ureteral Access SheathY-11-362026-02-10
06970462547570Single-use Ureteral Access SheathY-11-452026-02-10
06970462547587Single-use Ureteral Access SheathY-11-552026-02-10
06970462547594Single-use Ureteral Access SheathY-12-362026-02-10
06970462547600Single-use Ureteral Access SheathY-12-452026-02-10
06970462547617Single-use Ureteral Access SheathY-12-552026-02-10
16970462546716Broncho SamplerBS012026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207066805NARichard Wolf GmbHFBN2026-06-02
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.EOQ2026-06-02
04055207007709NARichard Wolf GmbHFBN2026-05-29
04055207007723RIWORichard Wolf GmbHFBN2026-05-29
04055207007747NARichard Wolf GmbHFBN2026-05-29
04055207007792NARichard Wolf GmbHFBN2026-05-29
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
04055207038536RIWORichard Wolf GmbHFBN2026-05-29
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
08881300750107F88SG ENDOSCOPY PTE. LTD.FGB2025-06-30
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
08033638801048Pen LEDSAPI MED SPANTN2023-08-02
10618125131041DEXcam3™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
10618125155870DEXcam4™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
10195594671501CARDINAL HEALTHCardinal Health 200, LLCKQM2022-05-31
10195594436452CARDINAL HEALTHCardinal Health 200, LLCKQM2021-12-02