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FDA 510(k)

MobileRay Pulse SE Digital Imaging System

K-Number: K191503 · 2019-09-04

ApplicantPortavision Medical, LLC
Decision Date2019-09-04
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MobileRay Pulse SE Digital Imaging System is a medical device manufactured by Portavision Medical, LLC. It received FDA 510(k) clearance on 2019-09-04 under approval number K191503. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MobileRay Pulse SE Digital Imaging System?

MobileRay Pulse SE Digital Imaging System is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Portavision Medical, LLC. The 510(k) number is K191503.

When was MobileRay Pulse SE Digital Imaging System approved by the FDA?

MobileRay Pulse SE Digital Imaging System received FDA 510(k) clearance on 2019-09-04, under approval number K191503.

What company makes MobileRay Pulse SE Digital Imaging System?

MobileRay Pulse SE Digital Imaging System is manufactured by Portavision Medical, LLC.

What is the FDA product code for MobileRay Pulse SE Digital Imaging System?

The FDA product code for MobileRay Pulse SE Digital Imaging System is OWB.

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 NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) 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: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Portavision Medical, LLC

K212557Virtual C DRF-NEO Digital Imaging System K211191Virtual C DRF Digital Imaging System

Related Devices (Code: OWB)

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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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