Cleared Traditional

MAXIO (K132108) - FDA 510(k) Clearance

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

K132108 · Perfint Healthcare Pvt, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
315d
Days
Class 2
Risk

K132108 is an FDA 510(k) clearance for the MAXIO. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Perfint Healthcare Pvt, Ltd. (Philedelphia, US). The FDA issued a Cleared decision on May 19, 2014 after a review of 315 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 Perfint Healthcare Pvt, Ltd. devices

Submission Details

510(k) Number K132108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2013
Decision Date May 19, 2014
Days to Decision 315 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
208d slower than avg
Panel avg: 107d · This submission: 315d
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 352
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K132108.
SOMATOM SCOPE/SOMATOM SCOPE POWER
K140912 · Siemens Medical Solutions USA, Inc. · Sep 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232 · Siemens Medical Solutions USA, Inc. · Aug 2014
SYNGO, CT DUAL ENERGY
K133648 · Siemens Medical Solutions USA, Inc. · Jul 2014
SOMATOM PERSPECTIVE
K133590 · Siemens Medical Solutions USA, Inc. · Apr 2014
SOMATOM FORCE
K133589 · Siemens Medical Solutions USA, Inc. · Apr 2014
SYNGO DUAL ENERGY SOFTWARE PACKAGE
K132902 · Siemens Medical Solutions USA, Inc. · Apr 2014