Cleared Traditional

K200990 - VIDAvision

K200990 is an FDA 510(k) clearance for VIDAvision, manufactured by Vida Diagnostics, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K200990 · Vida Diagnostics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
114d
Days
Class 2
Risk

K200990 is an FDA 510(k) clearance for the VIDAvision. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Vida Diagnostics, Inc. (Coralville, US). The FDA issued a Cleared decision on August 7, 2020 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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. Standard predicate reliance. 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 Vida Diagnostics, Inc. devices

FDA 510(k) Submission Details - K200990

510(k) Number K200990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2020
Decision Date August 07, 2020
Days to Decision 114 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
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 713
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K200990.
LSN
K201092 · Imaging Biometrics, LLC · Oct 2020
syngo.CT Neuro Perfusion
K202213 · Siemens Medical Solutions USA, Inc. · Oct 2020
Clear Guide SCENERGY
K201188 · Clear Guide Medical · Sep 2020
Clear Guide SCENERGY
K201898 · Clear Guide Medical · Jul 2020
SOMATOM On.site and On.scene
K193277 · Siemens Medical Solutions USA, Inc. · Jul 2020
SCENARIA View
K200498 · Hitachi Healthcare Americas · Jul 2020