Cleared Traditional

EMORY CARDIAC TOOL BOX (K980914) - FDA 510(k) Clearance

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

K980914 · Emory University · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
85d
Days
Class 2
Risk

K980914 is an FDA 510(k) clearance for the EMORY CARDIAC TOOL BOX. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Emory University (Atlanta, US). The FDA issued a Cleared decision on June 4, 1998 after a review of 85 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.

View all Emory University devices

Submission Details

510(k) Number K980914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1998
Decision Date June 04, 1998
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - KPS System, Tomography, Computed, Emission

All 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K980914.
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · Toshiba America Medical Systems, In.C · Dec 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · Siemens Medical Solutions USA, Inc. · Oct 1998
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
K982300 · Toshiba America Medical Systems, In.C · Sep 1998
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · Siemens Medical Solutions USA, Inc. · Sep 1997
E. CAM COINCIDENCE MODE (CM)
K970627 · Siemens Medical Solutions USA, Inc. · Sep 1997
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997