Cleared Traditional

K131433 - ISYS 1 (U.S)

K131433 is an FDA 510(k) clearance for ISYS 1 (U.S), manufactured by Isys Medizintechnik GmbH. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K131433 · Isys Medizintechnik GmbH · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
298d
Days
Class 2
Risk

K131433 is an FDA 510(k) clearance for the ISYS 1 (U.S),ACCESSORY, NON-STERILE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Isys Medizintechnik GmbH (Stamford, US). The FDA issued a Cleared decision on March 11, 2014 after a review of 298 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 Isys Medizintechnik GmbH devices

FDA 510(k) Submission Details - K131433

510(k) Number K131433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date March 11, 2014
Days to Decision 298 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
191d slower than avg
Panel avg: 107d · This submission: 298d
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.

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All 636
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