Prodiva 1.5T CX and Prodiva 1.5T CS R5.4— 510(k) K173507

Clearance details

Applicant

Philips Healthcare (Suzhou) Co., Ltd.

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2017-11-13

Decision date

2018-06-15

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Suzhou, CN

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• K252992 — CT Rembra RT; CT Areta RT2026-03-23
• K260519 — Smart Fit TorsoCardiac 1.5T2026-03-20
• K242329 — CT Collaboration Live2024-11-18
• K232491 — CT 53002024-05-03
• K233600 — Smart Fit Knee 3.0T2024-02-05

Death

11

Injury

670

Malfunction

1,460

Other

2

Total

2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →