Neocoil: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Neocoil” (first 2007, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 4 | 4 |
Review panels
- Radiology (4)
Most recent Neocoil 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE | MOS | 2007-11-30 | 14 |
| K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | MOS | 2007-06-28 | 15 |
| K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | MOS | 2007-05-22 | 13 |
| K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL | MOS | 2007-04-11 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Neocoil.
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 Neocoil (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)
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.
- Neocoil, LLC (17 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neocoil?
FDA lists 4 510(k) clearances under the applicant name “Neocoil” (first 2007, latest 2007), 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 Neocoil?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neocoil is 14 days.
Which FDA product codes appear under Neocoil?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 4).
Next steps
- See all 4 Neocoil clearances with predicates and recalls
- Run predicate analysis for product code MOS, Neocoil'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.