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Access CT

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref 728114510(k) K191136Ref 728116

by Philips Healthcare (Suzhou) Co., Ltd.

Identity

Trade Name
Access CT EUDAMED
Device Name
CT Scanner System (Access CT) EUDAMED
Model / Reference
728114 EUDAMED
728116 EUDAMED

Identifiers

Primary DI / UDI-DI
00884838059856 EUDAMED
00884838059849 EUDAMED
Basic UDI-DI
0884838BM284T4 EUDAMED
Direct Marketing DI
00884838059856 EUDAMED
00884838059849 EUDAMED
EMDN Code
Z11030602 COMPUTED TOMOGRAPHS - EXCEEDING 2 LAYERS BUT LESS THAN 16 LAYERS EUDAMED
Z11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Access CT by Philips Healthcare (Suzhou) Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Philips Healthcare (Suzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000003923
Authorised Representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Sources (3)

  • EUDAMED 7581b825-8a38-4106-81e6-2229977ca8c4 85 fields · synced Jul 8, 2026
  • EUDAMED f1bac4d7-50a2-4833-8f24-12a032120b5e 61 fields · synced May 19, 2026
  • FDA 510(k) K191136 1 fields · synced May 18, 2026