Medic, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Medic, Inc.” (first 1993, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 120 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 | 11 | 11 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
- Radiology (12)
Most recent Medic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022395 | 1.5T SCANMED PV ARRAY | MOS | 2002-08-13 | 21 |
| K951649 | MODEL #801GE1500 PEDIATRIC ARRAY COIL | LNH | 1995-06-22 | 73 |
| K942874 | MODEL #300TO3500 SHOULDER COIL | LNH | 1994-12-08 | 174 |
| K942875 | MODEL #900TO3500 HEAD/NECK COIL | LNH | 1994-12-02 | 168 |
| K942873 | MODEL #700TO3500 NECK/ABDOMINAL COIL | LNH | 1994-12-02 | 168 |
| K942355 | MODEL #310T03500 WRIST COIL | LNH | 1994-09-16 | 122 |
| K940874 | MODEL 900GE1500 HEAD/NECK COIL | LNH | 1994-06-03 | 98 |
| K933296 | MODEL #310GE1500 WRIST COIL | LNH | 1994-03-17 | 253 |
| K933295 | MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA | LNH | 1994-03-17 | 253 |
| K933659 | MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL | LNH | 1993-11-22 | 118 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medic, 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 Medic, Inc. (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.
- Medic Evaluation Devices & Instruments Corp. (1 510(k)s)
- Medic Group of Scandinavia, Inc. (1 510(k)s)
- Medic One (1 510(k)s)
- Medic Sharplight , Ltd. (1 510(k)s)
- Medic Vision Brain Technologies, Ltd. (1 510(k)s)
- Medic Vision - Imaging Solutions, Ltd. (1 510(k)s)
- Medic Vision Imaging Solutions (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medic, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Medic, Inc.” (first 1993, latest 2002), 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 Medic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medic, Inc. is 120 days.
Which FDA product codes appear under Medic, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 11); MOS (Coil, Magnetic Resonance, Specialty, 1).
Next steps
- See all 12 Medic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Medic, 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.