Cleared Traditional

K073021 - MULTI-SPECT

K073021 is an FDA 510(k) clearance for MULTI-SPECT, manufactured by Eagle Heart Imaging, LLC. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K073021 · Eagle Heart Imaging, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
11d
Days
Class 2
Risk

K073021 is an FDA 510(k) clearance for the MULTI-SPECT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Eagle Heart Imaging, LLC (Westminster, US). The FDA issued a Cleared decision on November 6, 2007 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 - K073021

510(k) Number K073021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2007
Decision Date November 06, 2007
Days to Decision 11 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 470
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K073021.
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K072468 · Spectrum Dynamics , Ltd. · Oct 2007
K073021 · MULTI-SPECT
Download PDF FDA Summary Eagle Heart Imaging, …