FDA.reportPublic FDA data

pde-neoII

Primary DI
04582389010543
Brand
pde-neoII
Company
HAMAMATSU PHOTONICS K.K.
Model
C10935-400
Published
2016-09-23
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
IZISystem, X-Ray, Angiographic
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133719000PDE-NEOHamamatsu Photonics K.K.2014-03-27IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582389010543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582389010543045823890105434582389010543

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
704524537
Device count
1
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
04582389010734NanoZoomer S20MD Slide scanner systemC16300-01MD2026-08-03
04582389011236NanoZoomer S540MD Slide scanner systemC17400-01MD2026-08-03
04582389011267Agilent S540MD Slide Scanner SystemC17400-51MD2026-08-03
04582389010659NanoZoomer S360MD Slide scanner systemC13220-01MD2022-10-01
04582389010871PDE-GEN3C13999-402023-06-01
04582389010031PDEC9830-402016-09-23
04582389010062NIRO-200NXC10448-202016-09-23
04582389010093pde-neoC10935-402016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixIZI2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
04048551411704NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551425671NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551425688NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551426166NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551426180NAKarl Storz GmbH & Co. KGOWN2025-03-27
10884521816725VS3-IRVISIONSENSE LTD.OWN2024-11-11
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
00195278719263AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719577AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719720AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719744AlliaGE MEDICAL SYSTEMSIZI2023-12-08
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10841962118733Iris AirShuttle™QfixIZI2023-04-10
00195278485144AlliaGE MEDICAL SYSTEMSIZI2022-04-13
00195278485168AlliaGE MEDICAL SYSTEMSIZI2022-04-08
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059458NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
04953170424724Infrared imaging unitOLYMPUS MEDICAL SYSTEMS CORP.IZI2021-05-31
20193489066927NAMICMEDLINE INDUSTRIES, INC.IZI2021-05-12
00195278215543AlliaGE MEDICAL SYSTEMSIZI2021-03-31
00195278215550AlliaGE MEDICAL SYSTEMSIZI2021-03-31