Cleared Traditional

K051853 - CARDIOSTREAM SONOAIM

K051853 is an FDA 510(k) clearance for CARDIOSTREAM SONOAIM, manufactured by Cardiostream, LLC. 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.

K051853 · Cardiostream, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
45d
Days
Class 2
Risk

K051853 is an FDA 510(k) clearance for the CARDIOSTREAM SONOAIM. 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 Cardiostream, LLC (Clearwater, US). The FDA issued a Cleared decision on August 22, 2005 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 Cardiostream, LLC devices

FDA 510(k) Submission Details - K051853

510(k) Number K051853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2005
Decision Date August 22, 2005
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 1469
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K051853.
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C
K052344 · Eizo Nanao Corporation · Sep 2005
MONOCHROME LCD MONITOR, MODEL RADIFORCE G33
K052337 · Eizo Nanao Corporation · Sep 2005
AIDA COMPACT II SYSTEM
K052159 · KARL STORZ Endoscopy-America, Inc. · Sep 2005
NIO 3MP-21
K051901 · Barcoview · Aug 2005
ENSITE VERISMO SOFTWARE
K051840 · St Jude Medical · Aug 2005
NIO 2MP-21
K051902 · Barcoview · Aug 2005