Cleared Traditional

K811252 - MS-50 ULTRASONIC IMAGER

K811252 is an FDA 510(k) clearance for MS-50 ULTRASONIC IMAGER, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K811252 · Kontron Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
94d
Days
Class 2
Risk

K811252 is an FDA 510(k) clearance for the MS-50 ULTRASONIC IMAGER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981 after a review of 94 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K811252

510(k) Number K811252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1981
Decision Date August 07, 1981
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

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 426
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K811252.
ARTICULATED ARM B-SCANNER
K811426 · General Electric Co. · Aug 1981
NEEDLE GUIDE ATTACHMENT
K811931 · Technicare Corp. · Aug 1981
ATL'S MARK 100/300 ULTRASOUND SYSTEMS
K811572 · Advanced Technology Laboratories, Inc. · Aug 1981
5CM SMALL PARTS SCANNER
K810914 · Smithkline Diagnostics, Inc. · May 1981
OPHTHALMO ECHOGRAPH MODEL ZD255G
K802635 · Jedmed Instrument Co. · Apr 1981
MARK 500 SYSTEM
K810073 · Advanced Technology Laboratories, Inc. · Mar 1981