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)

dS Sentinelle Breast 16ch 1.5T Coil

K-Number: K213735 · 2022-08-08

ApplicantInvivo Corporation (Business Trade Name: Philips)
Decision Date2022-08-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

dS Sentinelle Breast 16ch 1.5T Coil is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2022-08-08 under 510(k) number K213735. 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 dS Sentinelle Breast 16ch 1.5T Coil?

dS Sentinelle Breast 16ch 1.5T Coil is a medical device that received FDA 510(k) clearance on 2022-08-08. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213735.

When did dS Sentinelle Breast 16ch 1.5T Coil receive FDA 510(k) clearance?

dS Sentinelle Breast 16ch 1.5T Coil received FDA 510(k) clearance on 2022-08-08, under 510(k) number K213735.

Who is the listed applicant for dS Sentinelle Breast 16ch 1.5T Coil?

The FDA 510(k) record lists Invivo Corporation (Business Trade Name: Philips) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dS Sentinelle Breast 16ch 1.5T Coil?

The FDA product code for dS Sentinelle Breast 16ch 1.5T Coil is MOS.

Other records listing Invivo Corporation (Business Trade Name: Philips) 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.

K232762dS Breast Coil 7ch 1.5TK2223258ch Wrist CoilK2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilK213727dS Sentinelle Breast 16ch 3.0T CoilK213351ds Head 32ch 3.0T

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.

↑