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FDA 510(k)

ActivSight Intraoperative Imaging System

K-Number: K203550 · 2021-04-08

ApplicantActiv Surgical, Inc.
Decision Date2021-04-08
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ActivSight Intraoperative Imaging System is a medical device manufactured by Activ Surgical, Inc.. It received FDA 510(k) clearance on 2021-04-08 under approval number K203550. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ActivSight Intraoperative Imaging System?

ActivSight Intraoperative Imaging System is a medical device that received FDA 510(k) clearance on 2021-04-08. It is manufactured by Activ Surgical, Inc.. The 510(k) number is K203550.

When was ActivSight Intraoperative Imaging System approved by the FDA?

ActivSight Intraoperative Imaging System received FDA 510(k) clearance on 2021-04-08, under approval number K203550.

What company makes ActivSight Intraoperative Imaging System?

ActivSight Intraoperative Imaging System is manufactured by Activ Surgical, Inc..

What is the FDA product code for ActivSight Intraoperative Imaging System?

The FDA product code for ActivSight Intraoperative Imaging System is OWN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Activ Surgical, Inc.

K231344ActivSight Intraoperative Imaging System

Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

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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