Cleared Traditional

K842093 - MK 700 ULTRASOUND SYSTEM

K842093 is an FDA 510(k) clearance for MK 700 ULTRASOUND SYSTEM, manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K842093 · Advanced Technology Laboratories, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
126d
Days
Class 2
Risk

K842093 is an FDA 510(k) clearance for the MK 700 ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 126 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 Advanced Technology Laboratories, Inc. devices

FDA 510(k) Submission Details - K842093

510(k) Number K842093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1984
Decision Date September 27, 1984
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
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 674
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K842093.
MECHANICAL SECTOR PROBE 4 MHZ DFM
K842880 · General Electric Co. · Dec 1984
AUTOFOCUS DUAL ELEMENT PROBE
K842777 · Technicare Corp. · Nov 1984
ULTRAMARK 4 ULTRASOUND SYS
K842376 · Advanced Technology Laboratories, Inc. · Oct 1984
MEDICAL DIAG. ULTRASOUND INSTR. 77065
K842897 · Hewlett-Packard Co. · Sep 1984
AMERICAN MEDICAL OPTICS IMAGING SYS
K842127 · American Medical Optics · Sep 1984
TECHNICARE 248 SL & 260SL
K841817 · Technicare Corp. · Aug 1984