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Prodiva 1.5T CX

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref 781070510(k) K173507Ref 781069

by Philips Healthcare (Suzhou) Co., Ltd.

Identity

Trade Name
Prodiva 1.5T CX EUDAMED
Prodiva 1.5T CS EUDAMED
Device Name
Prodiva 1.5T EUDAMED
Model / Reference
781070 EUDAMED
781069 EUDAMED

Identifiers

Primary DI / UDI-DI
00884838064805 EUDAMED
00884838064799 EUDAMED
Basic UDI-DI
0884838BM288TC EUDAMED
Direct Marketing DI
00884838064805 EUDAMED
00884838064799 EUDAMED
510(k) Number
K173507 FDA 510(k)
FDA Product Code
LNH FDA 510(k)
EMDN Code
Z11050103 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY GREATER THAN 0.5T EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Market of Registration
Germany EUDAMED
France EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

Prodiva 1.5T CX 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 08dc6ea0-de63-4baa-b0d5-b476194a5a7d 61 fields · synced Jul 10, 2026
  • FDA 510(k) K173507 24 fields · synced May 18, 2026
  • EUDAMED 3ef19184-c54c-41a6-a1e4-ea745fe8e2b5 61 fields · synced Jul 9, 2026