Cleared Traditional

K180697 - Pseudo-Patient

K180697 is the FDA 510(k) clearance for Pseudo-Patient by Rtsafe, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K180697 · Rtsafe, Inc. · Radiology device
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Jul 2018
Decision
116d
Days
Class 2
Risk

K180697 is an FDA 510(k) clearance for the Pseudo-Patient. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Rtsafe, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 10, 2018 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Rtsafe, Inc. devices

Submission Details

510(k) Number K180697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2018
Decision Date July 10, 2018
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Consultant

Jalex Medical, LLC
Jennifer Palinchik

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYE Accelerator, Linear, Medical

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