Cleared Traditional

K024149 - PRIMELUNG

K024149 is an FDA 510(k) clearance for PRIMELUNG, manufactured by Accuimage Diagnostics Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K024149 · Accuimage Diagnostics Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
67d
Days
Class 2
Risk

K024149 is an FDA 510(k) clearance for the PRIMELUNG. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Accuimage Diagnostics Corp. (South San Francisco, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 67 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.

FDA 510(k) Submission Details - K024149

510(k) Number K024149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date February 21, 2003
Days to Decision 67 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
40d faster than avg
Panel avg: 107d · This submission: 67d
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 805
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K024149.
CARD EP
K031261 · GE Medical Systems · May 2003
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K030420 · GE Medical Systems · Mar 2003
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K023785 · Philips Medical Systems (Cleveland), Inc. · Feb 2003
RADIOMED MARKER
K022326 · Radiomed Corporation · Jan 2003
SOMATOM EMOTION 6 CT SYSTEMS
K023687 · Siemens Medical Systems, Inc. · Nov 2002
K024149 · PRIMELUNG
Download PDF FDA Summary Accuimage Diagnostics…