Sicel Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sicel Technologies, Inc.” (first 2004, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| NZT | Dosimeter, Ionizing Radiation, Implanted | 2 | 2 |
Review panels
- Radiology (7)
Most recent Sicel Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | NZT | 2008-11-13 | 30 |
| K081859 | MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM | IYE | 2008-08-04 | 34 |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | NZT | 2008-01-23 | 21 |
| K071399 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 | LHN | 2007-06-20 | 30 |
| K061051 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER | LHN | 2006-06-13 | 57 |
| K052118 | DOSE VERIFICATION SYSTEM | LHN | 2006-04-03 | 242 |
| K040687 | ONEDOSE PATIENT DOSIMETRY SYSTEM | IYE | 2004-06-25 | 101 |
Recalls
openFDA lists no recalls under a recalling firm named Sicel Technologies, 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 Sicel Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Sicel Technologies, Inc.” (first 2004, latest 2008), 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 Sicel Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sicel Technologies, Inc. is 34 days.
Which FDA product codes appear under Sicel Technologies, Inc.?
The most frequent FDA product codes under this applicant name are LHN (System, Radiation Therapy, Charged-Particle, Medical, 3); IYE (Accelerator, Linear, Medical, 2); NZT (Dosimeter, Ionizing Radiation, Implanted, 2).
Next steps
- See all 7 Sicel Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHN, Sicel Technologies, 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.