FDA 510(k)

ds Head 32ch 3.0T

K-Number: K213351 · 2021-10-29

ApplicantInvivo Corporation (Business Trade Name: Philips)

Decision Date2021-10-29

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ds Head 32ch 3.0T is a medical device manufactured by Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2021-10-29 under approval number K213351. 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 Head 32ch 3.0T?

ds Head 32ch 3.0T is a medical device that received FDA 510(k) clearance on 2021-10-29. It is manufactured by Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213351.

When was ds Head 32ch 3.0T approved by the FDA?

ds Head 32ch 3.0T received FDA 510(k) clearance on 2021-10-29, under approval number K213351.

What company makes ds Head 32ch 3.0T?

ds Head 32ch 3.0T is manufactured by Invivo Corporation (Business Trade Name: Philips).

What is the FDA product code for ds Head 32ch 3.0T?

The FDA product code for ds Head 32ch 3.0T is MOS.

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

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 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.