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Philips CT 3500

by Philips Healthcare (Suzhou) Co., Ltd.

510(k) K223311Ref 728134

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223311↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM1060LT Basic UDI-DI 00884838111318UDI-DIDate11 Jul 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223311 Date22 Dec 2022ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM1060LT registered 11 Jul 2025 Active
  • FDA 510(k) K223311 decided 22 Dec 2022 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K223311
  2. Registered EUDAMED 0884838BM1060LT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device name
CT Scanner System (Philips CT 3500)
Model / reference
728134
Primary DI / UDI-DI
00884838111318
Basic UDI-DI
0884838BM1060LT
Direct marketing DI
00884838111318
510(k) Number
FDA product code
JAK
EMDN code
Z11030605 Computed tomographs - 64 layers or more but less than 128 layers
Device class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.1750
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIb
510(k)
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Philips CT 3500 is a computed tomography (CT) scanner designed for high-resolution imaging of the body. It provides detailed cross-sectional images of internal structures, enabling precise diagnosis and evaluation of anatomical and pathological conditions in radiology settings.

This device is intended for use in clinical environments where advanced imaging is required, supplied as a reusable medical system. It complies with FDA 510(k) clearance under the Radiology Advisory Committee and is authorized under the Medical Device Regulation (MDR). The system is intended for professional healthcare settings and requires appropriate training for operation.

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS.

Other devices from Philips Healthcare (Suzhou) Co., Ltd.

See all devices from Philips Healthcare (Suzhou) Co., Ltd. →

Properties

Other properties (14, all answered No)