Cleared Traditional

K843130 - SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4

K843130 is an FDA 510(k) clearance for SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4, 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 119-day FDA review.

K843130 · Advanced Technology Laboratories, Inc. · Cardiovascular device
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Dec 1984
Decision
119d
Days
Class 2
Risk

K843130 is an FDA 510(k) clearance for the SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1984 after a review of 119 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 - K843130

510(k) Number K843130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date December 06, 1984
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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 K843130.
ACCESS & 72X ULTRASOUND SCANHEAD UM4
K843131 · Advanced Technology Laboratories, Inc. · Dec 1984
ULTRASOUND 72X & ANNULAR ARRAY SCAN-
K843165 · Advanced Technology Laboratories, Inc. · Dec 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K843129 · Advanced Technology Laboratories, Inc. · Dec 1984
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
K843262 · Hewlett-Packard Co. · Aug 1984
VASCULAR RECORDER #301
K832369 · Imex Medical Systems, Inc. · Mar 1984
VASOSCAN
K833902 · Sonicaid, Inc. · Jan 1984