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

FDA 510(k)

Asimov-MKS Imaging System

K-Number: K192761 · 2020-01-17

ApplicantOnlume, Inc.
Decision Date2020-01-17
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Asimov-MKS Imaging System is a medical device manufactured by Onlume, Inc.. It received FDA 510(k) clearance on 2020-01-17 under approval number K192761. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Asimov-MKS Imaging System?

Asimov-MKS Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Onlume, Inc.. The 510(k) number is K192761.

When was Asimov-MKS Imaging System approved by the FDA?

Asimov-MKS Imaging System received FDA 510(k) clearance on 2020-01-17, under approval number K192761.

What company makes Asimov-MKS Imaging System?

Asimov-MKS Imaging System is manufactured by Onlume, Inc..

What is the FDA product code for Asimov-MKS Imaging System?

The FDA product code for Asimov-MKS Imaging System is IZI.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System 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 NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED

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)

Related Devices (Code: IZI)

K151780CAAS WorkstationPie Medical Imaging BV K162991YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec, AG K170239Leica FL560Leica Microsystems (Schweiz) AG K181537GLOW800Leica Microsystems (Schweiz) AG K180019CAAS WorkstationPie Medical Imaging BV K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.

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.

↑