Cleared Traditional

K811595 - SP-100-B SMALL PARTS SCANNER SYSTEM

K811595 is an FDA 510(k) clearance for SP-100-B SMALL PARTS SCANNER SYSTEM, manufactured by Highstoy. The device is a Class 2 Radiology device with product code DXK cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K811595 · Highstoy · Radiology device
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Aug 1981
Decision
65d
Days
Class 2
Risk

K811595 is an FDA 510(k) clearance for the SP-100-B SMALL PARTS SCANNER SYSTEM. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Highstoy (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2330 - 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 Highstoy devices

FDA 510(k) Submission Details - K811595

510(k) Number K811595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1981
Decision Date August 12, 1981
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K811595.
CARDIOSCAN - TM BEING APPLIED FOR
K841263 · Interspec, Inc. · Oct 1984
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
SKI 5000
K812646 · Smithkline Diagnostics, Inc. · Nov 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · Advanced Technology Laboratories, Inc. · Jan 1981
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980