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FDA 510(k)

InkSpace Imaging Small Body Array (SBA12PH30x)

K-Number: K253182 · 2025-10-20

ApplicantInkspace Imaging, Inc.
Decision Date2025-10-20
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InkSpace Imaging Small Body Array (SBA12PH30x) is a medical device manufactured by Inkspace Imaging, Inc.. It received FDA 510(k) clearance on 2025-10-20 under approval number K253182. 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 (SBA12PH30x)?

InkSpace Imaging Small Body Array (SBA12PH30x) is a medical device that received FDA 510(k) clearance on 2025-10-20. It is manufactured by Inkspace Imaging, Inc.. The 510(k) number is K253182.

When was InkSpace Imaging Small Body Array (SBA12PH30x) approved by the FDA?

InkSpace Imaging Small Body Array (SBA12PH30x) received FDA 510(k) clearance on 2025-10-20, under approval number K253182.

What company makes InkSpace Imaging Small Body Array (SBA12PH30x)?

InkSpace Imaging Small Body Array (SBA12PH30x) is manufactured by Inkspace Imaging, Inc..

What is the FDA product code for InkSpace Imaging Small Body Array (SBA12PH30x)?

The FDA product code for InkSpace Imaging Small Body Array (SBA12PH30x) is MOS.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT05707806 Development and Validation of Learning and Decision-Making Tasks RECRUITING NCT01421953 Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers COMPLETED NCT00702533 A New Method for Determining Gastric Acid Output Using a Wireless Capsule COMPLETED NCT05642195 Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer SUSPENDED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41437380 Applications of artificial intelligence in non-small cell lung cancer: from precision diagnosis to personalized prognosis and therapy. Journal of translational medicine (2025)

Other Devices by Inkspace Imaging, Inc.

K213397InkSpace Imaging Pediatric Body Array K223487InkSpace Imaging Body Array K243675InkSpace Imaging Small Body Array K233444InkSpace Imaging Small Body Array

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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.

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