Cleared Traditional

K912516 - CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.#...

K912516 is an FDA 510(k) clearance for CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.#..., manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K912516 · Continental X-Ray Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
166d
Days
Class 2
Risk

K912516 is an FDA 510(k) clearance for the CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 166 days - an extended review 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: 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K912516

510(k) Number K912516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date November 19, 1991
Days to Decision 166 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 107d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
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 - IZZ Table, Radiographic, Non-tilting, Powered

All 16
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K912516.
SHIMADZU RADIOGRAPHIC TABLE BK-100
K925174 · Shimadzu Medical Systems · Nov 1992
CATHERIZATION KS-50
K920732 · Shimadzu Medical Systems · Apr 1992
CAT-250B
K915413 · Toshiba America Medical Systems, In.C · Dec 1991
CLASSIC 4-WAY ELEVATING TABLE
K912474 · Continental X-Ray Corp. · Sep 1991
HUGH YOUNG II UROLOGICAL TABLE
K891403 · Mallinckrodt Group, Inc. · Jun 1989
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · Warner-Lambert Co. · Jun 1989