Cleared Traditional

K965105 - ELECTROPHYSIOLOGY TILT TABLE MODEL #9660

K965105 is an FDA 510(k) clearance for ELECTROPHYSIOLOGY TILT TABLE MODEL #9660, manufactured by U.S. Imaging Tables, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K965105 · U.S. Imaging Tables, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
41d
Days
Class 2
Risk

K965105 is an FDA 510(k) clearance for the ELECTROPHYSIOLOGY TILT TABLE MODEL #9660. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by U.S. Imaging Tables, Inc. (Happauge, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 41 days - a notably fast clearance cycle.

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: 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 U.S. Imaging Tables, Inc. devices

FDA 510(k) Submission Details - K965105

510(k) Number K965105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date January 30, 1997
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
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 46
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K965105.
LEGACY/LEGACY-D TABLE
K973039 · GE Medical Systems · Oct 1997
CAP-35B III/CINE 275
K971128 · Jamieson Film Co. · Apr 1997
PHILIPS EASY DIAGNOST
K970640 · Philips Medical Systems North America, Inc. · Mar 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