Cleared Traditional

K172058 - CT6485

K172058 is an FDA 510(k) clearance for CT6485, manufactured by Analogic Corporation. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K172058 · Analogic Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172058

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.

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 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K172058.
syngo.CT Clinical Extensions
K173625 · Siemens Medical Solutions USA, Inc. · Mar 2018
uCT Computed Tomography X-ray System
K172135 · Shanghai United Imaging Healthcare Co., Ltd. · Mar 2018
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
K173468 · Toshibamedical Systems Corporation · Feb 2018
superDimension Navigation System V7.2
K173244 · Covidien, LLC · Feb 2018
OnSight 3D Extremity System
K173478 · Carestream Health, Inc. · Jan 2018
NeuViz 16 Essence Multi-slice CT Scanner System
K171198 · Neusoft Medical Systems Co., Ltd. · Dec 2017