Odin Medical Technologies , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Odin Medical Technologies , Ltd.” (first 2001, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 4 | 4 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
- Radiology (5)
Most recent Odin Medical Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050237 | STARSHIELD V3 RF TRNT | LNH | 2005-03-18 | 44 |
| K032541 | POLESTAR N-20 | LNH | 2003-09-12 | 25 |
| K022157 | RF TENT | LNH | 2002-08-28 | 57 |
| K020601 | FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL | MOS | 2002-04-24 | 61 |
| K010850 | POLESTAR N-10 | LNH | 2001-12-17 | 271 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-07-01.
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 Odin Medical Technologies , Ltd. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Odin Medical Limited (3 510(k)s)
- Odin Technologies , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Odin Medical Technologies , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Odin Medical Technologies , Ltd.” (first 2001, latest 2005), 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 Odin Medical Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Odin Medical Technologies , Ltd. is 57 days.
Which FDA product codes appear under Odin Medical Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 4); MOS (Coil, Magnetic Resonance, Specialty, 1).
Next steps
- See all 5 Odin Medical Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Odin Medical Technologies , Ltd.'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.