Smart Fit TorsoCardiac 1.5T— 510(k) K260519
Substantially EquivalentPhilips 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.. Device class: 2.
Summary
Philips Healthcare (Suzhou)'s Smart Fit TorsoCardiac 1.5T is filed under MOS, specialty magnetic resonance coils. The record doesn't describe the coil beyond its name and that code name.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. It was a Special 510(k).
Philips Healthcare (Suzhou) filed from Suzhou, China. The decision came 31 calendar days after receipt (February 17 to March 20, 2026).
Clearance details
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
- Product code
- Product code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Suzhou, CN
Recent devices under product code MOS
view all- K262813 — InkSpace Imaging Small Body Array (SBA12PH15x)
- K262330 — dS 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 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260947 — 0.55T 12Ch Breast Coil
- K252587 — HD 8Ch Wrist Array
More clearances from Philips Healthcare (Suzhou) Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.