Cleared Traditional

K032823 - MEDICHEART, MODEL RELEASE 1

K032823 is an FDA 510(k) clearance for MEDICHEART, manufactured by Medicsight. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K032823 · Medicsight · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
61d
Days
Class 2
Risk

K032823 is an FDA 510(k) clearance for the MEDICHEART, MODEL RELEASE 1. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Medicsight (London, GB). The FDA issued a Cleared decision on November 10, 2003 after a review of 61 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 Medicsight devices

FDA 510(k) Submission Details - K032823

510(k) Number K032823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2003
Decision Date November 10, 2003
Days to Decision 61 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
46d faster than avg
Panel avg: 107d · This submission: 61d
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 686
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K032823.
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · Ge Medical Systems, LLC · Nov 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · Siemens Medical Solutions USA, Inc. · Nov 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · Siemens Medical Solutions USA, Inc. · Nov 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418 · Toshiba America Medical Systems, In.C · Nov 2003
ADVANTAGE 4D OPTION
K032915 · Ge Medical Systems, LLC · Oct 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · Philips Medical Systems, Inc. · Oct 2003