Cleared Traditional

K942190 - ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE

K942190 is an FDA 510(k) clearance for ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE, manufactured by Image Diagnostics, Inc.. The device is a Class 2 Radiology device with product code IXQ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K942190 · Image Diagnostics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
105d
Days
Class 2
Risk

K942190 is an FDA 510(k) clearance for the ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE. Classified as Table, Radiographic, Stationary Top (product code IXQ), Class II - Special Controls.

Submitted by Image Diagnostics, Inc. (Sterling, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 105 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 Image Diagnostics, Inc. devices

FDA 510(k) Submission Details - K942190

510(k) Number K942190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date August 17, 1994
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXQ Device Classification - Class 2, Special Controls

Product Code IXQ Table, Radiographic, Stationary Top
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 - IXQ Table, Radiographic, Stationary Top

All 8
Devices cleared under the same product code (IXQ) and FDA review panel - the closest regulatory comparables to K942190.
CARBON FIBER CONFORMAL COUCH TOP
K973842 · Medtec, Inc. · Dec 1997
MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
K960083 · Wuestec Medical, Inc. · Jul 1996
MED-TEC HAND GRIP
K954225 · Medtec, Inc. · Nov 1995
BUCKY TABLE BK-12
K920729 · Shimadzu Medical Systems · Apr 1992
MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130
K912382 · Continental X-Ray Corp. · Oct 1991
LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS
K903160 · Continental X-Ray Corp. · Aug 1990