Smart Fit TorsoCardiac 1.5T— 510(k) K260519

Substantially Equivalent

Philips Healthcare (Suzhou) Co., Ltd.

FDA 510(k) clearance K260519 for Smart Fit TorsoCardiac 1.5T, Substantially Equivalent on 2026-03-20. Applicant: Philips Healthcare (Suzhou) Co., Ltd..

Clearance details

Applicant: Philips Healthcare (Suzhou) Co., Ltd.
Product code: Code MOS
Advisory panel: Radiology
Date received: 2026-02-17
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Suzhou, CN

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