FDA 510(k)

InkSpace Imaging Body Array

K-Number: K223487 · 2022-12-08

Decision Date2022-12-08

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

InkSpace Imaging Body Array is a medical device manufactured by Inkspace Imaging, Inc.. It received FDA 510(k) clearance on 2022-12-08 under approval number K223487. 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 InkSpace Imaging Body Array?

InkSpace Imaging Body Array is a medical device that received FDA 510(k) clearance on 2022-12-08. It is manufactured by Inkspace Imaging, Inc.. The 510(k) number is K223487.

When was InkSpace Imaging Body Array approved by the FDA?

InkSpace Imaging Body Array received FDA 510(k) clearance on 2022-12-08, under approval number K223487.

What company makes InkSpace Imaging Body Array?

InkSpace Imaging Body Array is manufactured by Inkspace Imaging, Inc..

What is the FDA product code for InkSpace Imaging Body Array?

The FDA product code for InkSpace Imaging Body Array is MOS.

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Other Devices by Inkspace Imaging, Inc.

K213397InkSpace Imaging Pediatric Body Array K243675InkSpace Imaging Small Body Array K233444InkSpace Imaging Small Body Array K253182InkSpace Imaging Small Body Array (SBA12PH30x)

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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.