Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012563754

FEI Number

3012563754

Entity Name

Philips Medical Systems Nederland B.V.

City/State/Country

Best Noord-Brabant, NL

Establishment Address

Veenpluis 6, Best Noord-Brabant 5684 PC, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241871

PMA Number

N/A

All Registered Proprietary Names

Philips IntelliSite Pathology Solution 5.1 Philips IntelliSite Pathology Solution 5.1 Philips IntelliSite Pathology Solution

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	2025-03-11
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2024-06-25
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2024-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Pedroza Business: Philips Email: martin.pedroza@philips.com Phone: (440) 2197243

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1	2025-03-06

Similar Registrations

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3008491142	FUJIFILM Healthcare Americas Corporation	Lexington, MA, US
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
9614683	HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION	HAMAMATSU CITY Shizuoka, JP
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 3012563754. Last updated year: 2026. Please use registration number 3012563754 when referencing this establishment in official correspondence.