Cleared Traditional

K071584 - OASIS RELEASE 1.0

K071584 is an FDA 510(k) clearance for OASIS RELEASE 1.0, manufactured by Segami Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K071584 · Segami Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
81d
Days
Class 2
Risk

K071584 is an FDA 510(k) clearance for the OASIS 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 Segami Corporation (Columbia, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 81 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 Segami Corporation devices

FDA 510(k) Submission Details - K071584

510(k) Number K071584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2007
Decision Date August 31, 2007
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
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 1354
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K071584.
COLOR LCD MONITOR, FLEXSCAN MX300W
K073340 · Eizo Nanao Corporation · Dec 2007
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007
GE ECHOPAC
K072952 · General Electric Co. · Nov 2007
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
K072065 · Totoku Electric Co., Ltd. · Aug 2007
1.3M MONOCHROME LCD MONITOR MDL1908A
K072066 · Totoku Electric Co., Ltd. · Aug 2007
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007