Cleared Traditional

K855161 - UPRIGHT BUCKY STAND/MOUNT

K855161 is an FDA 510(k) clearance for UPRIGHT BUCKY STAND/MOUNT, manufactured by X-Ray Systems. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K855161 · X-Ray Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
48d
Days
Class 2
Risk

K855161 is an FDA 510(k) clearance for the UPRIGHT BUCKY STAND/MOUNT. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by X-Ray Systems (Fraser, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 48 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 X-Ray Systems devices

FDA 510(k) Submission Details - K855161

510(k) Number K855161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 12, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 107d · This submission: 48d
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 297
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K855161.
BC 1400 HAND POSITIONER
K872316 · Instrumentation Industries, Inc. · Aug 1987
BC 1800 FINGER POSITIONER
K872317 · Instrumentation Industries, Inc. · Aug 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987
DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
K853753 · Victoreen, Inc. · Oct 1985
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · General Electric Co. · Dec 1981
DSS 500
K811934 · Philips Medical Systems (Cleveland), Inc. · Aug 1981