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FDA 510(k)

InkSpace Imaging Small Body Array

K-Number: K233444 · 2024-01-08

ApplicantInkspace Imaging, Inc.
Decision Date2024-01-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InkSpace Imaging Small 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 2024-01-08 under 510(k) number K233444. 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 Small Body Array?

InkSpace Imaging Small Body Array is a medical device that received FDA 510(k) clearance on 2024-01-08. The listed applicant is Inkspace Imaging, Inc.. The 510(k) number is K233444.

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

InkSpace Imaging Small Body Array received FDA 510(k) clearance on 2024-01-08, under 510(k) number K233444.

Who is the listed applicant for InkSpace Imaging Small 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 Small Body Array?

The FDA product code for InkSpace Imaging Small 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 ArrayK223487InkSpace Imaging Body ArrayK213397InkSpace Imaging Pediatric Body Array

Related Devices (Code: MOS)

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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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