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FDA 510(k)

Smart Fit TorsoCardiac 1.5T

K-Number: K260519 · 2026-03-20

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2026-03-20
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart Fit TorsoCardiac 1.5T is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K260519. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Fit TorsoCardiac 1.5T?

Smart Fit TorsoCardiac 1.5T is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K260519.

When did Smart Fit TorsoCardiac 1.5T receive FDA 510(k) clearance?

Smart Fit TorsoCardiac 1.5T received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260519.

Who is the listed applicant for Smart Fit TorsoCardiac 1.5T?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Fit TorsoCardiac 1.5T?

The FDA product code for Smart Fit TorsoCardiac 1.5T is MOS.

Other records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252992CT Rembra RT; CT Areta RT; CT RembraK242329CT Collaboration LiveK232491CT 5300K233600Smart Fit Knee 3.0TK232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TK223311Philips CT 3500

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Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive OnlyShenzhen RF Tech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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