Cleared Traditional

K010813 - SIMPLICT

K010813 is an FDA 510(k) clearance for SIMPLICT, manufactured by Neorad AS. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K010813 · Neorad AS · Radiology device
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May 2001
Decision
49d
Days
Class 2
Risk

K010813 is an FDA 510(k) clearance for the SIMPLICT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Neorad AS (Chapel Hill, US). The FDA issued a Cleared decision on May 7, 2001 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neorad AS devices

FDA 510(k) Submission Details - K010813

510(k) Number K010813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2001
Decision Date May 07, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
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 712
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K010813.
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141 · Shimadzu Corp. · Jul 2001
MX8000 V5.0 CT SYSTEM
K010817 · Philips Medical Systems (Cleveland), Inc. · Jun 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · E-Z-Em, Inc. · May 2001
GE CT-PET SYSTEM
K010641 · Ge Medical Systems, Inc. · Mar 2001
CT PERFUSION 2
K010042 · General Electric Co. · Jan 2001
VITREA 2 CT PERFUSION OPTION
K003639 · Vital Images, Inc. · Jan 2001