FDA.reportPublic FDA data

lmaging Processor System (lncluding Light Source)

Primary DI
06973786290139
Brand
lmaging Processor System (lncluding Light Source)
Company
Shanghai SeeGen Photoelectric Technology Co., Ltd
Model
PL-2100
Published
2023-07-26
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
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241532000Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd.2024-10-22FET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973786290181PackageGS11In Commercial Distribution
06973786290139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697378629018116973786290181
06973786290139069737862901396973786290139

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing/light source systemA mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416472832
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973786290368Disposable Endoscope Valves KitSG-DVK-FJ-7002024-10-25
06973786291563Flexible Video-CholedochoscopeCHV-110J-U2025-03-20
16973786290518Flexible Video-CholedochoscopeCHV-110J-U2025-03-20
06973786291570Flexible Video-CholedochoscopeCHV-US120J-U2025-03-19
06973786290559Flexible Video-Choledo-Cysto-UreteroscopeCHV-100-E2023-07-26
06973786290566Flexible Video-Choledo-Cysto-UreteroscopeCHV-100T-E2023-07-26
06973786290573Flexible Video-Choledo-Cysto-UreteroscopeCHV-US100-H2023-07-26
06973786290641Flexible Video-CholedochoscopeCHV-US100J-U2023-07-26
06973786290658Flexible Video-CholedochoscopeCHV-US110J-U2023-07-26
06973786290078lmaging Processor System (lncluding Light Source)PL-10002023-07-26
06973786290337Disposable Endoscope Valves KitSG-DVK-OL-2002024-10-25
06973786290344Disposable Endoscope Valves KitSG-DVK-OL-200E2024-10-25
06973786290375Disposable Endoscope Valves KitSG-DVK-FJ-700E2024-10-25
06973786290399Disposable Endoscope Valves KitSG-DVK-PT-I10902024-10-25
06973786290405Disposable Endoscope Valves KitSG-DVK-PT-I1090E2024-10-25
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(STD)2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(STD)2024-09-14
06973786290627Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(REV)2023-07-26
06973786290634Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(REV)2023-07-26
06973786290580Flexible Video-Choledo-Cysto-UreteroscopeUV-100-E2023-07-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
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
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
04048551425695n.a.Karl Storz GmbH & Co. KGFET2024-12-20
04250480101704NASCHÖLLY FIBEROPTIC GmbHFET2024-12-03
04048551436271n.a.Karl Storz GmbH & Co. KGFET2024-11-28
04048551436240n.a.Karl Storz GmbH & Co. KGFET2024-10-18
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
14714127861392AESCULAPAesculap AGKQM2023-11-05
00887761967267Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGKQM2023-07-11