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FDA 510(k)

dS Sentinelle Breast 16ch 3.0T Coil

K-Number: K213727 · 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 3.0T Coil is a medical device manufactured by Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2022-08-08 under approval number K213727. 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 3.0T Coil?

dS Sentinelle Breast 16ch 3.0T Coil is a medical device that received FDA 510(k) clearance on 2022-08-08. It is manufactured by Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213727.

When was dS Sentinelle Breast 16ch 3.0T Coil approved by the FDA?

dS Sentinelle Breast 16ch 3.0T Coil received FDA 510(k) clearance on 2022-08-08, under approval number K213727.

What company makes dS Sentinelle Breast 16ch 3.0T Coil?

dS Sentinelle Breast 16ch 3.0T Coil is manufactured by Invivo Corporation (Business Trade Name: Philips).

What is the FDA product code for dS Sentinelle Breast 16ch 3.0T Coil?

The FDA product code for dS Sentinelle Breast 16ch 3.0T Coil is MOS.

Other Devices by Invivo Corporation (Business Trade Name: Philips)

K213351ds Head 32ch 3.0T K2223258ch Wrist Coil K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K213735dS Sentinelle Breast 16ch 1.5T Coil K232762dS Breast Coil 7ch 1.5T

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.

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