Cleared Traditional

K803049 - DIGITAL RADIOGRAPHY CHEST DEVICE

K803049 is an FDA 510(k) clearance for DIGITAL RADIOGRAPHY CHEST DEVICE, 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 91-day FDA review.

K803049 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Mar 1981
Decision
91d
Days
Class 2
Risk

K803049 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY CHEST DEVICE. 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 March 2, 1981 after a review of 91 days - within the typical 510(k) review window.

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: 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K803049

510(k) Number K803049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date March 02, 1981
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
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 K803049.
UROSKOP C
K811807 · Siemens Corp. · Aug 1981
SYSTEM 400
K810973 · Philips Medical Systems (Cleveland), Inc. · May 1981
LOW DOSE SERVOCHEST
K810797 · Philips Medical Systems (Cleveland), Inc. · Apr 1981
MULTIX U. BUCKY TABLE X-RAY UNIT
K803130 · Siemens Corp. · Jan 1981
VERTIX 3D-U
K802200 · Siemens Corp. · Oct 1980
SIREGRAPH C
K800788 · Siemens Medical Solutions USA, Inc. · May 1980