Cleared Traditional

K810118 - LS1000 ELECTRONIC FOCUS

K810118 is the FDA 510(k) clearance for LS1000 ELECTRONIC FOCUS by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K810118 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Feb 1981
Decision
34d
Days
Class 2
Risk

K810118 is an FDA 510(k) clearance for the LS1000 ELECTRONIC FOCUS. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 K810118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1981
Decision Date February 19, 1981
Days to Decision 34 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
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 787
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K810118.
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
DOPPLER IMAGING OPTION
K840140 · Hewlett-Packard Co. · Aug 1984
ACCESS SCANHEADSS
K840953 · Advanced Technology Laboratories, Inc. · Jun 1984
DIASONICS SMALL PARTS SCANNER
K802979 · Diasonics, Inc. · Jan 1981
TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX
K801972 · Advanced Technology Laboratories, Inc. · Oct 1980
RA-I
K781642 · Diasonics, Inc. · Oct 1978