Cleared Traditional

K001201 - MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS

K001201 is an FDA 510(k) clearance for MULTIX COMPACT K AND MULTIX L RADIOGRAP..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K001201 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jun 2000
Decision
49d
Days
Class 2
Risk

K001201 is an FDA 510(k) clearance for the MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on June 1, 2000 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K001201

510(k) Number K001201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2000
Decision Date June 01, 2000
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 264
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K001201.
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DR5000 DEDICATED CHEST X-RAY SYSTEM
K001341 · Analogic Corp. · Jun 2000
PENSIL TRAUMA, MODEL WWS6100
K993962 · Wuestec Medical, Inc. · Dec 1999
LEGEND CRF FLUORO AND RAD SYSTEM
K993665 · Ge Medical Systems, Inc. · Nov 1999
SILHOUETTE FC
K993090 · Ge Medical Systems, Inc. · Oct 1999