Cleared Traditional

K914417 - MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE

K914417 is an FDA 510(k) clearance for MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080..., manufactured by Med-Vac, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K914417 · Med-Vac, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
147d
Days
Class 2
Risk

K914417 is an FDA 510(k) clearance for the MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Med-Vac, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 147 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 Med-Vac, Inc. devices

FDA 510(k) Submission Details - K914417

510(k) Number K914417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1991
Decision Date February 27, 1992
Days to Decision 147 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
40d slower than avg
Panel avg: 107d · This submission: 147d
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 49
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K914417.
X-RAY DIAGNOSTIC TABLE YSF-100
K920728 · Shimadzu Medical Systems · May 1992
HYDRAJUST IV UROLOGICAL TABLE
K920742 · Mallinckrodt Group, Inc. · Apr 1992
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
K920722 · Shimadzu Medical Systems · Apr 1992
MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
K912996 · Continental X-Ray Corp. · Feb 1992
TANGENT V
K915853 · Fischer Imaging Corp. · Jan 1992
X-RAY TABLE
K914165 · Siemens Medical Solutions USA, Inc. · Nov 1991