Cleared Traditional

K981056 - VARIAN XIMATRON SCAN VISION CT

K981056 is an FDA 510(k) clearance for VARIAN XIMATRON SCAN VISION CT, manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K981056 · Varian Medical Systems, Inc. · Radiology device
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Jun 1998
Decision
81d
Days
Class 2
Risk

K981056 is an FDA 510(k) clearance for the VARIAN XIMATRON SCAN VISION CT. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on June 12, 1998 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Varian Medical Systems, Inc. devices

FDA 510(k) Submission Details - K981056

510(k) Number K981056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1998
Decision Date June 12, 1998
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 283
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K981056.
DX-480, ADD ON DIGITAL IMAGER
K981880 · Wuestec Medical, Inc. · Oct 1998
DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K982196 · GE Medical Systems · Oct 1998
PHILIPS THORAVISION
K981657 · Philips Medical Systems North America, Inc. · Jun 1998
OLDELFT DIGIDELCA
K980296 · Oldelft Corp. of America · Apr 1998
IMIX DIGITAL THORAX SYSTEM
K974863 · Advanced Instrument Development, Inc. · Mar 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597 · Bayer Corp., Agfa Div. · Mar 1998