Cleared Traditional

K843165 - ULTRASOUND 72X & ANNULAR ARRAY SCAN-

K843165 is an FDA 510(k) clearance for ULTRASOUND 72X & ANNULAR ARRAY SCAN-, manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K843165 · Advanced Technology Laboratories, Inc. · Cardiovascular device
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Dec 1984
Decision
129d
Days
Class 2
Risk

K843165 is an FDA 510(k) clearance for the ULTRASOUND 72X & ANNULAR ARRAY SCAN-. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 20, 1984 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Technology Laboratories, Inc. devices

FDA 510(k) Submission Details - K843165

510(k) Number K843165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date December 20, 1984
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 54
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K843165.
SCANHEADS ACCESS 10 10PV B10
K843953 · Advanced Technology Laboratories, Inc. · Mar 1985
ACCESS C
K843911 · Advanced Technology Laboratories, Inc. · Mar 1985
ACCESS & 72X ULTRASOUND SCANHEAD UM4
K843131 · Advanced Technology Laboratories, Inc. · Dec 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K843129 · Advanced Technology Laboratories, Inc. · Dec 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4
K843130 · Advanced Technology Laboratories, Inc. · Dec 1984
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
K843262 · Hewlett-Packard Co. · Aug 1984