Cleared Traditional

K973834 - CS2000 & CS2000 TOMO

K973834 is an FDA 510(k) clearance for CS2000 & CS2000 TOMO, manufactured by Pausch Corp.. The device is a Class 2 Radiology device with product code IZF cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K973834 · Pausch Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
204d
Days
Class 2
Risk

K973834 is an FDA 510(k) clearance for the CS2000 & CS2000 TOMO. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Pausch Corp. (Tenton Falls, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 204 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 Pausch Corp. devices

FDA 510(k) Submission Details - K973834

510(k) Number K973834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1997
Decision Date April 30, 1998
Days to Decision 204 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
97d slower than avg
Panel avg: 107d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZF Device Classification - Class 2, Special Controls

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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 - IZF System, X-ray, Tomographic

All 32
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K973834.
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
K132261 · Ge Medical Systems, LLC · Nov 2013
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
K121499 · Fujifilm Medical System U.S.A., Inc. · Nov 2012
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
K973864 · Pausch Corp. · Jun 1998
LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270
K950571 · Continental X-Ray Corp. · Mar 1995
BENNETT X-RAY TOMOGRAPHY SYSTEM
K945749 · Bennett X-Ray Corp. · Feb 1995
TOMO-LINK
K944967 · GE Medical Systems · Dec 1994