Smart Fit TorsoCardiac 1.5T
K-Number: K260519 · 2026-03-20
Decision Date2026-03-20
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Smart Fit TorsoCardiac 1.5T is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-20 under approval 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. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K260519.
When was Smart Fit TorsoCardiac 1.5T approved by the FDA?
Smart Fit TorsoCardiac 1.5T received FDA 510(k) clearance on 2026-03-20, under approval number K260519.
What company makes Smart Fit TorsoCardiac 1.5T?
Smart Fit TorsoCardiac 1.5T is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
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 Devices by Philips Healthcare (Suzhou) Co., Ltd.
Related Devices (Code: MOS)
K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC
K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC
K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC
K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation
K16202916ch T/R Knee CoilQuality Electrodynamics, LLC
K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.
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.