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FDA 510(k)

dS Breast Coil 7ch 1.5T

K-Number: K232762 · 2023-10-03

ApplicantInvivo Corporation (Business Trade Name: Philips)
Decision Date2023-10-03
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

dS Breast Coil 7ch 1.5T is a medical device manufactured by Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2023-10-03 under approval number K232762. 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 Breast Coil 7ch 1.5T?

dS Breast Coil 7ch 1.5T is a medical device that received FDA 510(k) clearance on 2023-10-03. It is manufactured by Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K232762.

When was dS Breast Coil 7ch 1.5T approved by the FDA?

dS Breast Coil 7ch 1.5T received FDA 510(k) clearance on 2023-10-03, under approval number K232762.

What company makes dS Breast Coil 7ch 1.5T?

dS Breast Coil 7ch 1.5T is manufactured by Invivo Corporation (Business Trade Name: Philips).

What is the FDA product code for dS Breast Coil 7ch 1.5T?

The FDA product code for dS Breast Coil 7ch 1.5T 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 K213727dS Sentinelle Breast 16ch 3.0T Coil

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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