Cleared Traditional

CURA 16 (K173076) - FDA 510(k) Clearance

Also marketed or referenced as:
ScintCare CT16

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173076 · Fmi Medical Systems, Inc. · Radiology device
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Oct 2018
Decision
370d
Days
Class 2
Risk

K173076 is an FDA 510(k) clearance for the CURA 16. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Fmi Medical Systems, Inc. (Solon, US). The FDA issued a Cleared decision on October 4, 2018 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Fmi Medical Systems, Inc. devices

Submission Details

510(k) Number K173076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date October 04, 2018
Days to Decision 370 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
263d slower than avg
Panel avg: 107d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

FDA 510k Consultants, LLC
Paul McFeely

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.

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