Cleared Traditional

K972686 - VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER

K972686 is an FDA 510(k) clearance for VCAR OPTION TO THE DST AND DST-XL GAMMA..., manufactured by Smv America. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K972686 · Smv America · Radiology device
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Oct 1997
Decision
89d
Days
Class 2
Risk

K972686 is an FDA 510(k) clearance for the VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Smv America (Twinsburg, US). The FDA issued a Cleared decision on October 14, 1997 after a review of 89 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 Smv America devices

FDA 510(k) Submission Details - K972686

510(k) Number K972686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1997
Decision Date October 14, 1997
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
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 355
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K972686.
QUEST PET IMAGING SYSTEM
K973396 · Ugm Medical Systems, Inc. · Jan 1998
IMAGE FUSION AND REVIEW SYSTEM
K973233 · Adac Laboratories · Nov 1997
MCD-AC
K971980 · Adac Laboratories · Oct 1997
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
K965226 · Lunar Corp. · Oct 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · Siemens Medical Solutions USA, Inc. · Sep 1997
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER
K972509 · Nuccardiac Software, Inc. · Sep 1997