Cleared Traditional

K980959 - VTRANSACT: ATTENUATION CORRECTION SYSTE...

K980959 is an FDA 510(k) clearance for VTRANSACT: ATTENUATION CORRECTION SYSTE..., manufactured by Ge Medical Systems F.I. Haifa. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K980959 · Ge Medical Systems F.I. Haifa · Radiology device
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Jun 1998
Decision
82d
Days
Class 2
Risk

K980959 is an FDA 510(k) clearance for the VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA C.... Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems F.I. Haifa (Tirat Hacarmel, IL). The FDA issued a Cleared decision on June 4, 1998 after a review of 82 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 Ge Medical Systems F.I. Haifa devices

FDA 510(k) Submission Details - K980959

510(k) Number K980959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1998
Decision Date June 04, 1998
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - KPS System, Tomography, Computed, Emission

All 251
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K980959.
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3D-MSPECT
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K980715 · Adac Laboratories · May 1998
IMAGE FUSION AND REVIEW SYSTEM
K973233 · Adac Laboratories · Nov 1997
MCD-AC
K971980 · Adac Laboratories · Oct 1997