Cleared Traditional

K963851 - TILTING RADIOGRAPHIC TABLE (REMOTE)

K963851 is an FDA 510(k) clearance for TILTING RADIOGRAPHIC TABLE (REMOTE), manufactured by Acoma Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K963851 · Acoma Medical Imaging, Inc. · Radiology device
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Jan 1997
Decision
120d
Days
Class 2
Risk

K963851 is an FDA 510(k) clearance for the TILTING RADIOGRAPHIC TABLE (REMOTE). Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on January 23, 1997 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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. Standard predicate reliance. 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 Acoma Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K963851

510(k) Number K963851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date January 23, 1997
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 47
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K963851.
PHILIPS EASY DIAGNOST
K970640 · Philips Medical Systems North America, Inc. · Mar 1997
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K965105 · U.S. Imaging Tables, Inc. · Jan 1997
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
K965096 · U.S. Imaging Tables, Inc. · Jan 1997
TANGENT VI TABLE
K961022 · Fischer Imaging Corp. · May 1996
COMPAX 90/15E
K954356 · General Electric Co. · Oct 1995
KOORDINAT M
K951176 · Siemens Medical Solutions USA, Inc. · Apr 1995