Mri Devices Corp.: FDA clearances and approvals
Mri Devices Corp. has 76 FDA 510(k) clearances (first 1991, latest 2005), across 3 product codes in 2 review panels. Median 510(k) review time: 26 days.
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 | 65 | 65 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 10 | 10 |
| NEU | Marker, Radiographic, Implantable | 1 | 1 |
Review panels
- Radiology (75)
- General and Plastic Surgery (1)
Most recent Mri Devices Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050622 | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL | MOS | 2005-04-08 | 29 |
| K050621 | NVA-127-8-A NEUROVASCULAR ARRAY COIL | MOS | 2005-04-07 | 28 |
| K050514 | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS | MOS | 2005-03-25 | 24 |
| K050299 | HRK-123 KNEE ARRAY COIL | MOS | 2005-02-24 | 17 |
| K042103 | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL | MOS | 2004-08-16 | 12 |
| K041286 | DYNACAD V1.0 | LNH | 2004-07-21 | 69 |
| K041481 | MODEL BBC-127 BIOPSY BREAST COIL | MOS | 2004-07-19 | 46 |
| K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL | MOS | 2004-03-09 | 26 |
| K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL | MOS | 2004-03-09 | 26 |
| K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | MOS | 2004-03-05 | 28 |
66 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mri Devices Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Mri Devices Corp.'s product codes (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)
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- 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)
Frequently asked questions
How many FDA 510(k) clearances does Mri Devices Corp. have?
Mri Devices Corp. has 76 FDA 510(k) clearances (first 1991, latest 2005), across 3 product codes in 2 review panels.
How long does FDA take to clear Mri Devices Corp.'s 510(k)s?
The median time from FDA receipt to decision across Mri Devices Corp.'s cleared 510(k)s is 26 days.
What devices does Mri Devices Corp. make?
Its most frequent FDA product codes are MOS (Coil, Magnetic Resonance, Specialty, 65); LNH (System, Nuclear Magnetic Resonance Imaging, 10); NEU (Marker, Radiographic, Implantable, 1).
Has Mri Devices Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mri Devices Corp. Related entities may recall under other names.
Next steps
- See all 76 Mri Devices Corp. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Mri Devices Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.