Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InkSpace Imaging Small Body Array

K-Number: K243675 · 2024-12-20

ApplicantInkspace Imaging, Inc.
Decision Date2024-12-20
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 2024-12-20 under 510(k) number K243675. 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 2024-12-20. The listed applicant is Inkspace Imaging, Inc.. The 510(k) number is K243675.

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

InkSpace Imaging Small Body Array received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243675.

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)K233444InkSpace Imaging Small Body ArrayK223487InkSpace Imaging Body ArrayK213397InkSpace Imaging Pediatric Body Array

Related Devices (Code: MOS)

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.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

Official Source

View on FDA Database →

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

↑