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FDA 510(k)

InkSpace Imaging Pediatric Body Array

K-Number: K213397 · 2021-12-17

ApplicantInkspace Imaging, Inc.
Decision Date2021-12-17
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InkSpace Imaging Pediatric Body Array is a medical device manufactured by Inkspace Imaging, Inc.. It received FDA 510(k) clearance on 2021-12-17 under approval number K213397. 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 Pediatric Body Array?

InkSpace Imaging Pediatric Body Array is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Inkspace Imaging, Inc.. The 510(k) number is K213397.

When was InkSpace Imaging Pediatric Body Array approved by the FDA?

InkSpace Imaging Pediatric Body Array received FDA 510(k) clearance on 2021-12-17, under approval number K213397.

What company makes InkSpace Imaging Pediatric Body Array?

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

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

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

Related Clinical Trials

NCT02716441 Rotator Cuff Failure With Continuity ACTIVE_NOT_RECRUITING NCT07550361 Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients WITHDRAWN NCT05989646 Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children RECRUITING NCT07254351 Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics RECRUITING NCT07528547 Hypersight and Ethos In Pediatric Radiotherapy RECRUITING NCT06841575 Advancing Pediatric Retinal Imaging With Auto-aligned OCT RECRUITING

Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Inkspace Imaging, Inc.

K223487InkSpace Imaging 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.

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