Cleared Traditional

K811295 - DIGITAL NOISE REDUCER

K811295 is the FDA 510(k) clearance for DIGITAL NOISE REDUCER by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K811295 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jun 1981
Decision
43d
Days
Class 2
Risk

K811295 is an FDA 510(k) clearance for the DIGITAL NOISE REDUCER. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Walker, US). The FDA issued a Cleared decision on June 23, 1981 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K811295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date June 23, 1981
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 132
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K811295.
FLUORICON L300 IMAGE INTENSIFIER
K812775 · General Electric Co. · Nov 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561 · General Electric Co. · Oct 1981
CARDIAC 1000 TM
K811094 · American Edwards Laboratories · Jul 1981
DIGITAL RADIOGRAPHY SYSTEM
K810364 · Adac Laboratories · Mar 1981
SIRECON COMPACT
K810189 · Siemens Corp. · Mar 1981
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K802953 · General Electric Co. · Jan 1981