Cleared Traditional

K121418 - PLANMED VERITY

K121418 is the FDA 510(k) clearance for PLANMED VERITY by Planmed OY. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K121418 · Planmed OY · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
266d
Days
Class 2
Risk

K121418 is an FDA 510(k) clearance for the PLANMED VERITY. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on February 1, 2013 after a review of 266 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 Planmed OY devices

Submission Details

510(k) Number K121418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2012
Decision Date February 01, 2013
Days to Decision 266 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
159d slower than avg
Panel avg: 107d · This submission: 266d
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 582
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K121418.
AQUILION LB TRITON V4.91
K123500 · Toshibamedical Systems Corporation · May 2013
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
K123509 · Hitachi Medical Systems America, Inc. · Mar 2013
SYNGO, CT BONE READING
K123584 · Siemens Medical Solutions USA, Inc. · Mar 2013
SYNGO, CT CARDIAC FUNCTION
K123585 · Siemens Medical Solutions USA, Inc. · Dec 2012
AQUILION ONE VISION, V4.90
K122109 · Toshiba America Medical Systems, In.C · Sep 2012
GSI VIEWER WITH VUE OPTION
K121827 · GE Medical Systems SCS · Sep 2012