Nuccardiac Software, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Nuccardiac Software, Inc.” (first 1988, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 7 | 7 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
Review panels
- Radiology (12)
Most recent Nuccardiac Software, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972509 | CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER | KPS | 1997-09-08 | 67 |
| K970288 | CLINICAL DIAGNOSTIC SOFTWARE | KPS | 1997-04-24 | 90 |
| K944720 | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION | KPS | 1994-12-23 | 91 |
| K942363 | CEQUAL-QUANTITATIVE ANALYSIS | KPS | 1994-09-16 | 122 |
| K932701 | CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS | IYX | 1994-03-29 | 299 |
| K922671 | CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS | KPS | 1992-08-11 | 68 |
| K915644 | CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS | KPS | 1992-02-27 | 72 |
| K914296 | CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC | KPS | 1991-11-27 | 63 |
| K905222 | CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0 | LLZ | 1990-12-26 | 36 |
| K900697 | CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS | LLZ | 1990-05-11 | 87 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nuccardiac Software, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nuccardiac Software, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Nuccardiac Software, Inc.” (first 1988, latest 1997), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nuccardiac Software, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuccardiac Software, Inc. is 88 days.
Which FDA product codes appear under Nuccardiac Software, Inc.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 7); LLZ (System, Image Processing, Radiological, 4); IYX (Camera, Scintillation (Gamma), 1).
Next steps
- See all 12 Nuccardiac Software, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Nuccardiac Software, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.