Cleared Traditional

K900697 - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS

K900697 is an FDA 510(k) clearance for CEDARS-SINAI QUANTITATIVE THALLIUM-201 ..., manufactured by Nuccardiac Software, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K900697 · Nuccardiac Software, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
87d
Days
Class 2
Risk

K900697 is an FDA 510(k) clearance for the CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS. 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 Nuccardiac Software, Inc. (Torba Linda, US). The FDA issued a Cleared decision on May 11, 1990 after a review of 87 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 Nuccardiac Software, Inc. devices

FDA 510(k) Submission Details - K900697

510(k) Number K900697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date May 11, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 1713
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K900697.
INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS
K902428 · GE Medical Systems · Nov 1990
KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP
K904590 · Eastman Kodak Company · Nov 1990
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K903196 · General Electric Co. · Aug 1990
LITEBOX DIAGNOSTIC REVIEW WORKSTATION
K901158 · Siemens Gammasonics, Inc. · Apr 1990
MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
K900586 · Medrad, Inc. · Feb 1990
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)
K896050 · Fujifilm Medical System U.S.A., Inc. · Dec 1989