Calgary Scientific, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Calgary Scientific, Inc.” (first 2006, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 122 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 | 1 | 100 |
| 2013 | 1 | 154 |
| 2014 | 1 | 132 |
| 2015 | 0 | — |
| 2016 | 1 | 125 |
| 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 8 | 8 |
Review panels
- Radiology (8)
Most recent Calgary Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161130 | ResolutionMD | LLZ | 2016-08-24 | 125 |
| K133508 | RESOLUTIONMD MOBILE | LLZ | 2014-03-26 | 132 |
| K123186 | RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 | LLZ | 2013-03-14 | 154 |
| K120076 | RESOLUTIONMD WEB | LLZ | 2012-04-19 | 100 |
| K111346 | RESOLUTIONMD MOBILE MODEL RMB-MOB-2X | LLZ | 2011-09-09 | 119 |
| K082693 | RESOLUTIONMD, RELEASE 2.1 | LLZ | 2009-02-23 | 161 |
| K071086 | RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 | LLZ | 2007-06-01 | 45 |
| K062164 | RESOLUTIONMD, VERSION 1.3 | LLZ | 2006-09-22 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Calgary Scientific, 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 Calgary Scientific, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Calgary Scientific, Inc.” (first 2006, latest 2016), across 1 product code 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 Calgary Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Calgary Scientific, Inc. is 122 days.
Which FDA product codes appear under Calgary Scientific, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 8).
Next steps
- See all 8 Calgary Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Calgary Scientific, 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.