Cleared Traditional

CT6485, CT12885 (K172058) - FDA 510(k) Clearance

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

K172058 · Analogic Corporation · Radiology device
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Feb 2018
Decision
222d
Days
Class 2
Risk

K172058 is an FDA 510(k) clearance for the CT6485, CT12885. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Analogic Corporation (Peabody, US). The FDA issued a Cleared decision on February 13, 2018 after a review of 222 days - an extended review cycle.

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 Analogic Corporation devices

Submission Details

510(k) Number K172058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2017
Decision Date February 13, 2018
Days to Decision 222 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
115d slower than avg
Panel avg: 107d · This submission: 222d
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 Peers - JAK System, X-ray, Tomography, Computed

All 450
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K172058.
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K173244 · Covidien, LLC · Feb 2018
OnSight 3D Extremity System
K173478 · Carestream Health, Inc. · Jan 2018
Philips CT Big Bore
K171850 · Philips Medical Systems (Cleveland), Inc. · Nov 2017