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FDA 510(k)

InkSpace Imaging Body Array

K-Number: K223487 · 2022-12-08

ApplicantInkspace Imaging, Inc.
Decision Date2022-12-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InkSpace Imaging Body Array is the device name listed in this FDA 510(k) record. The listed applicant is Inkspace Imaging, Inc.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) 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. The listed applicant is Inkspace Imaging, Inc.. The 510(k) number is K223487.

When did InkSpace Imaging Body Array receive FDA 510(k) clearance?

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

Who is the listed applicant for InkSpace Imaging Body Array?

The FDA 510(k) record lists Inkspace Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Inkspace Imaging, Inc. 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.

K253182InkSpace Imaging Small Body Array (SBA12PH30x)K243675InkSpace Imaging Small Body ArrayK233444InkSpace Imaging Small Body ArrayK213397InkSpace Imaging Pediatric Body Array

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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.

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