Cleared Traditional

K963983 - E. CAM PROFILE ATTENUATION CORRECTION

K963983 is an FDA 510(k) clearance for E. CAM PROFILE ATTENUATION CORRECTION, manufactured by Siemens Corp.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K963983 · Siemens Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
178d
Days
Class 2
Risk

K963983 is an FDA 510(k) clearance for the E. CAM PROFILE ATTENUATION CORRECTION. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Corp. (Hoffman Estates, US). The FDA issued a Cleared decision on March 31, 1997 after a review of 178 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Siemens Corp. devices

FDA 510(k) Submission Details - K963983

510(k) Number K963983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date March 31, 1997
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 385
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K963983.
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K964834 · Park Medical Systems, Inc. · Feb 1997
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997