Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nuccardiac Software, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
203 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972509CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THENuccardiac Software, Inc.1997-09-08670
K970288CLINICAL DIAGNOSTIC SOFTWARENuccardiac Software, Inc.1997-04-24900
K944720COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTIONNuccardiac Software, Inc.1994-12-23910
K942363CEQUAL-QUANTITATIVE ANALYSISNuccardiac Software, Inc.1994-09-161220
K932701CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSISNuccardiac Software, Inc.1994-03-292990
K922671CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSISNuccardiac Software, Inc.1992-08-11680
K915644CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSISNuccardiac Software, Inc.1992-02-27720
K914296CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPECNuccardiac Software, Inc.1991-11-27630
K905222CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0Nuccardiac Software, Inc.1990-12-26360
K900697CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSISNuccardiac Software, Inc.1990-05-11870
K892397MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSISNuccardiac Software, Inc.1989-10-272030
K882271CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYNuccardiac Software, Inc.1988-11-031560

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda