Cleared Abbreviated

K202388 - Apolo D / Apolo S (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K202388 · Vmi Tecnologias Ltda · Radiology device
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Dec 2020
Decision
102d
Days
Class 2
Risk

K202388 is an FDA 510(k) clearance for the Apolo D / Apolo S. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Vmi Tecnologias Ltda (Aparecido De Oliveira, Lagoa Santa, BR). The FDA issued a Cleared decision on December 1, 2020 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vmi Tecnologias Ltda devices

Submission Details

510(k) Number K202388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2020
Decision Date December 01, 2020
Days to Decision 102 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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.

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