Cleared Traditional

K071086 - RESOLUTIONMD CARDIAC PRODUCT FAMILY

K071086 is an FDA 510(k) clearance for RESOLUTIONMD CARDIAC PRODUCT FAMILY, manufactured by Calgary Scientific, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K071086 · Calgary Scientific, Inc. · Radiology device
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Jun 2007
Decision
45d
Days
Class 2
Risk

K071086 is an FDA 510(k) clearance for the RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Calgary Scientific, Inc. (Calgary, Alberta, CA). The FDA issued a Cleared decision on June 1, 2007 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Calgary Scientific, Inc. devices

FDA 510(k) Submission Details - K071086

510(k) Number K071086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2007
Decision Date June 01, 2007
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K071086.
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007
REGIUS UNITEA
K071436 · Konica Minolta Medical & Graphic, Inc. · Jun 2007
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
K071232 · Tomtec Imaging Systems GmbH · Jun 2007
VITAL CONNECT 4.1
K071362 · Vital Images, Inc. · May 2007
VITREA VERSION 4.0
K071331 · Vital Images, Inc. · May 2007
SYNGO IMAGING (VERSION V30)
K071114 · Siemens AG Medical Solutions · May 2007