Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614683

FEI Number

3003794634

Entity Name

HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION

City/State/Country

HAMAMATSU CITY Shizuoka, JP

Establishment Address

812 JOKO-CHO, CHUO-KU, HAMAMATSU CITY Shizuoka --, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

HAMAMATSU PHOTONICS, K.K. (Owner Number: 8031665)

Owner / Operator Contact Address

325-6 SUNAYAMA-CHO, CHUO-KU, --, HAMAMATSU CITY, JP-22 430-8587, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110480

PMA Number

N/A

All Registered Proprietary Names

NanoZoomer S360MD Slide scanner system+ BARCO monitor NanoZoomer S360MD Slide scanner system NIRO-200NX PDE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2024-01-03
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2022-09-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-10-21
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2015-10-21
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2013-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

Teresa Carroll Business: HAMAMATSU CORP. Email: tcarroll@hamamatsu.com Phone: (732) 5373601

Related Public Records

Same Entity

HAMAMATSU PHOTONICS, K.K.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1	2025-03-06
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3012563754	Philips Medical Systems Nederland B.V.	Best Noord-Brabant, NL
3008491142	FUJIFILM Healthcare Americas Corporation	Lexington, MA, US
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
1000181154	BARCO S.R.L.	Saronno Varese, IT
3017125738	PAIGE.AI, INC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614683. Last updated year: 2026. Please use registration number 9614683 when referencing this establishment in official correspondence.