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FDA 510(k)

VFSS Pro Mobile Digital Imaging System

K-Number: K212523 · 2021-11-05

ApplicantImagexray, LLC
Decision Date2021-11-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VFSS Pro Mobile Digital Imaging System is a medical device manufactured by Imagexray, LLC. It received FDA 510(k) clearance on 2021-11-05 under approval number K212523. 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 VFSS Pro Mobile Digital Imaging System?

VFSS Pro Mobile Digital Imaging System is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Imagexray, LLC. The 510(k) number is K212523.

When was VFSS Pro Mobile Digital Imaging System approved by the FDA?

VFSS Pro Mobile Digital Imaging System received FDA 510(k) clearance on 2021-11-05, under approval number K212523.

What company makes VFSS Pro Mobile Digital Imaging System?

VFSS Pro Mobile Digital Imaging System is manufactured by Imagexray, LLC.

What is the FDA product code for VFSS Pro Mobile Digital Imaging System?

The FDA product code for VFSS Pro Mobile Digital Imaging System is OWB.

Related Clinical Trials

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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)

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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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