Cleared Traditional

K934311 - INTRASCAN(R) MINI-PACS

K934311 is an FDA 510(k) clearance for INTRASCAN MINI-PACS, manufactured by Markcare Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K934311 · Markcare Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
103d
Days
Class 2
Risk

K934311 is an FDA 510(k) clearance for the INTRASCAN(R) MINI-PACS. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Markcare Medical Systems, Inc. (Maywood, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 103 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 Markcare Medical Systems, Inc. devices

FDA 510(k) Submission Details - K934311

510(k) Number K934311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1993
Decision Date December 13, 1993
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
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 695
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K934311.
CAPASEE
K933747 · Toshiba America Medical Systems, In.C · May 1994
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · GE Medical Systems · Mar 1994
FULL VIEW DIGITAL STORAGE SYSTEM
K934908 · International Imaging Electronics · Jan 1994
CVI-Q(TM) OPTION FOR P700
K924184 · Philips Medical Systems, Inc. · Dec 1993
MEDISON 1500
K924432 · Medison Co., Ltd. · Nov 1993
MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM
K930579 · Medison America, Inc. · Nov 1993