Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

K-Number: K232021 · 2023-09-01

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2023-09-01
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 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 2023-09-01 under 510(k) number K232021. 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 and Smart Fit Shoulder 1.5T?

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K232021.

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

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232021.

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

The FDA product code for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 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 RembraK260519Smart Fit TorsoCardiac 1.5TK242329CT Collaboration LiveK232491CT 5300K233600Smart Fit Knee 3.0TK223311Philips CT 3500

View all 16 devices →

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.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) 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.

↑