Usa Instruments, Inc.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Usa Instruments, Inc.” (first 1997, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 56 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 | 63 | 63 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (64)
Most recent Usa Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY | MOS | 2005-11-09 | 23 |
| K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | MOS | 2005-10-07 | 14 |
| K052584 | 1.5T 12 CHANNEL BODY ARRAY | MOS | 2005-10-07 | 17 |
| K052585 | 3T HD BREAST ARRAY | MOS | 2005-10-04 | 14 |
| K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES | MOS | 2005-06-28 | 99 |
| K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL | MOS | 2004-09-24 | 25 |
| K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | MOS | 2004-08-26 | 10 |
| K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY | MOS | 2004-08-26 | 14 |
| K042009 | MARK III PHASED ARRAY SHOULDER COIL | MOS | 2004-08-11 | 16 |
| K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE | LNH | 2004-07-23 | 31 |
54 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-03-19.
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 Usa Instruments, 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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Usa Instruments, Inc.?
FDA lists 64 510(k) clearances under the applicant name “Usa Instruments, Inc.” (first 1997, 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 Usa Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Usa Instruments, Inc. is 56 days.
Which FDA product codes appear under Usa Instruments, Inc.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 63); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Next steps
- See all 64 Usa Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Usa Instruments, 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.