Cleared Traditional

K811934 - DSS 500

K811934 is an FDA 510(k) clearance for DSS 500, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K811934 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Aug 1981
Decision
38d
Days
Class 2
Risk

K811934 is an FDA 510(k) clearance for the DSS 500. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 38 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.

FDA 510(k) Submission Details - K811934

510(k) Number K811934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date August 13, 1981
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 357
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K811934.
ARMBOARD
K833559 · Mtd, Inc. · Jan 1984
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · General Electric Co. · Dec 1981
KERMATH L/C ARM
K812332 · Kermath Mfg. Corp. · Sep 1981
UROSKOP C
K811807 · Siemens Corp. · Aug 1981
X-CELL X-RAY #'S P-75W/P-75M
K811230 · X-Cel X-Ray Corp. · Jun 1981
KERMATH RADIOGRAPHIC HEAD STAND
K811215 · Kermath Mfg. Corp. · Jun 1981
K811934 · DSS 500
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