Sentinelle Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sentinelle Medical, Inc.” (first 2006, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 15 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Hologic, based on public ownership records.
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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (5)
Most recent Sentinelle Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103274 | SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING | MOS | 2011-08-18 | 286 |
| K100113 | VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 | MOS | 2010-04-22 | 98 |
| K093672 | AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION | LLZ | 2009-12-11 | 14 |
| K070244 | AEGIS | LLZ | 2007-02-09 | 15 |
| K060873 | VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS | MOS | 2006-04-14 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Sentinelle Medical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sentinelle Medical, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sentinelle Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sentinelle Medical, Inc.” (first 2006, latest 2011), across 2 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 Sentinelle Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sentinelle Medical, Inc. is 15 days.
Which FDA product codes appear under Sentinelle Medical, Inc.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 3); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 5 Sentinelle Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Sentinelle Medical, 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.