Cleared Traditional

PHILIPS SDR 1200 (K842900) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842900 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
143d
Days
Class 2
Risk

K842900 is an FDA 510(k) clearance for the PHILIPS SDR 1200. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on December 13, 1984 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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, Inc. devices

Submission Details

510(k) Number K842900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date December 13, 1984
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 107d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 181
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K842900.
KITECKO ULTRASOUND STANDOFF PAD
K851982 · 3M Company · Aug 1985
HIGH RESOLUTION 5 MHZ LINEAR ARRAY
K844449 · Siemens Medical Solutions USA, Inc. · Jan 1985
RT-50
K843320 · General Electric Co. · Dec 1984
MECHANICAL SECTOR PROBE 4 MHZ DFM
K842880 · General Electric Co. · Dec 1984
MEDICAL DIAG. ULTRASOUND INSTR. 77065
K842897 · Hewlett-Packard Co. · Sep 1984
QTA PROCESSOR MODULE
K840138 · General Electric Co. · Apr 1984