Cleared Traditional

K971452 - MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE

K971452 is an FDA 510(k) clearance for MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K971452 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
23d
Days
Class 2
Risk

K971452 is an FDA 510(k) clearance for the MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 23 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.

FDA 510(k) Submission Details - K971452

510(k) Number K971452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date May 14, 1997
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
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 28
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K971452.
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K930273 · Raymax Medical Corp. · Jul 1993
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K924444 · Control-X, Inc. · Feb 1993
K971452 · MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
Download PDF FDA Summary Siemens Medical Solut…