Cleared Traditional

K050736 - IMORGON ULTRASOUND PACS SOLUTIONS

K050736 is an FDA 510(k) clearance for IMORGON ULTRASOUND PACS SOLUTIONS, manufactured by Sea Ridge Software, 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.

K050736 · Sea Ridge Software, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
45d
Days
Class 2
Risk

K050736 is an FDA 510(k) clearance for the IMORGON ULTRASOUND PACS SOLUTIONS. 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 Sea Ridge Software, Inc. (San Leandro, US). The FDA issued a Cleared decision on May 5, 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 Sea Ridge Software, Inc. devices

FDA 510(k) Submission Details - K050736

510(k) Number K050736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date May 05, 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 1483
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K050736.
19-INCH (48 CM) COLOR LCD MONITOR CDL1902A
K051331 · Totoku Electric Co., Ltd. · Jun 2005
E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY
K051201 · Barcoview · May 2005
GE VIEWPOINT
K050943 · General Electric Co. · May 2005
20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB
K050619 · Totoku Electric Co., Ltd. · Apr 2005
21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB
K050617 · Totoku Electric Co., Ltd. · Apr 2005
21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB
K050616 · Totoku Electric Co., Ltd. · Apr 2005