Cleared Traditional

K223133 - VisiRad XR

K223133 is an FDA 510(k) clearance for VisiRad XR, manufactured by Imidex, Inc.. The device is a Class 2 Radiology device with product code MYN cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K223133 · Imidex, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
304d
Days
Class 2
Risk

K223133 is an FDA 510(k) clearance for the VisiRad XR. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Imidex, Inc. (Denver, US). The FDA issued a Cleared decision on August 3, 2023 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Imidex, Inc. devices

FDA 510(k) Submission Details - K223133

510(k) Number K223133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date August 03, 2023
Days to Decision 304 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 107d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYN Device Classification - Class 2, Special Controls

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MYN Analyzer, Medical Image

All 36
Devices cleared under the same product code (MYN) and FDA review panel - the closest regulatory comparables to K223133.
Lung-CAD
K230085 · Imagen Technologies, Inc. · Oct 2023
Overjet Periapical Radiolucency Assist
K231678 · Overjet, Inc. · Sep 2023
Lung-CAD
K223811 · Imagen Technologies, Inc. · Sep 2023
DTX Studio Clinic 3.0
K221921 · Nobel Biocare AB · Mar 2023
Overjet Caries Assist
K222746 · Overjet, Inc. · Mar 2023
Overjet Calculus Assist
K220928 · Overjet, Inc. · Dec 2022