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Philips IntelliSite Pathology Solution 5.x - IVDR

by Philips Medical Systems Nederland B.V.

Ref 760042

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k) De Novo

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241871↗

+3 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838121263 UDI-DI Date24 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK241871 Date2 Dec 2024IssuedStatusActive
European UnionCE/IVDR EUDAMED Number0884838BM847TU Basic UDI-DI 00884838121263UDI-DIDate30 Oct 2023RegisteredStatusActive
United StatesFDA De Novo De Novo NumberDEN160056 Date12 Apr 2017IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k), FDA De Novo Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Philips IntelliSite Pathology Solution 5.x - IVDR EUDAMED
Philips IntelliSite Pathology Solution GUDID
Generic Name
Microscope slide digital imaging scanner IVD
Model / Ref / Catalog
760042, 5.x IVDR
Primary DI / UDI-DI
00884838121263
Basic UDI-DI
0884838BM847TU
FDA Product Code
PSY
EMDN Code
W0202050304 Digital laboratory microscopes
GMDN Term
Microscope slide digital imaging scanner IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
864.3700
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
760042
GUDID
5.x IVDR
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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Properties

  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Serial Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No