Cleared Traditional

K970136 - DIGITAL ADD-ON BUCKY

K970136 is an FDA 510(k) clearance for DIGITAL ADD-ON BUCKY, manufactured by Swissray Teleray AG. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K970136 · Swissray Teleray AG · Radiology device
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Nov 1997
Decision
310d
Days
Class 2
Risk

K970136 is an FDA 510(k) clearance for the DIGITAL ADD-ON BUCKY. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Swissray Teleray AG (Liverpool, US). The FDA issued a Cleared decision on November 21, 1997 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Swissray Teleray AG devices

FDA 510(k) Submission Details - K970136

510(k) Number K970136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1997
Decision Date November 21, 1997
Days to Decision 310 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 107d · This submission: 310d
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 214
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K970136.
VARIAN XIMATRON SCAN VISION CT
K981056 · Varian Medical Systems, Inc. · Jun 1998
VACUDAP, MODEL 2000, 2001
K974112 · Victoreen, Inc. · Jan 1998
DIGITAL ADD ON MULTI SYSTEM
K973710 · Swissray International, Inc. · Dec 1997
AMBER DU
K973219 · Oldelft Corp. of America · Oct 1997
PIVOTING COMPENSATING FILTERS FOR THE HEAD
K972766 · Octostop, Inc. · Aug 1997
X-RAY ASSIST BAR
K972000 · Ralph Lindel, D.C. · Jul 1997