Cleared Traditional

K843891 - DOPSCAN PLUS DS1060

K843891 is an FDA 510(k) clearance for DOPSCAN PLUS DS1060, manufactured by Carolina Medical Electronics. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K843891 · Carolina Medical Electronics · Radiology device
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Jan 1985
Decision
99d
Days
Class 2
Risk

K843891 is an FDA 510(k) clearance for the DOPSCAN PLUS DS1060. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Carolina Medical Electronics (King, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 99 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 Carolina Medical Electronics devices

FDA 510(k) Submission Details - K843891

510(k) Number K843891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date January 09, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
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 682
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K843891.
CIVCO SCAN DRAPE
K844472 · CIVCO Medical Instruments Co., Inc. · Jan 1985
STORZ CORNEO-SCAN II CS2000
K844477 · Storz Instrument Co. · Jan 1985
ULTRASCAN DIGITAL B
K842757 · CooperVision, Inc. · Jan 1985
RT-50
K843320 · General Electric Co. · Dec 1984
PHILIPS SDR 1200
K842900 · Philips Medical Systems, Inc. · Dec 1984
MECHANICAL SECTOR PROBE 4 MHZ DFM
K842880 · General Electric Co. · Dec 1984