Northwest Medical Physics Equipment, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Northwest Medical Physics Equipment, Inc.” (first 1996, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 204 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 4 | 4 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 1 |
Review panels
- Radiology (6)
Most recent Northwest Medical Physics Equipment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063274 | ACCULOC BREAST LOCALIZATION SYSTEM | IYE | 2006-12-12 | 43 |
| K012575 | PREFERNCE IMRT TREATMENT PLANNING MODULE | MUJ | 2002-03-12 | 215 |
| K001833 | PREFERENCE TREATMENT SYSTEM | IYE | 2000-09-28 | 104 |
| K983793 | PREFERENCE TREATMENT SYSTEM | LNH | 1999-10-05 | 343 |
| K970464 | P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 | IYE | 1997-09-05 | 210 |
| K960293 | MRTOFLM COMPUTER PROGRAM | IYE | 1996-08-01 | 198 |
Recalls
7 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2006-04-07.
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 Northwest Medical Physics Equipment, 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 LNH)
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.
- Northwest Medical Physics Center (6 510(k)s)
- Northwest Orthodontics, Inc. (6 510(k)s)
- Northwest Biotech (2 510(k)s)
- Northwest Surgical Concepts, Inc. (2 510(k)s)
- Northwest Alabama Urological Assoc. (1 510(k)s)
- Northwest Orthopedics (1 510(k)s)
- Northwest Precision Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Northwest Medical Physics Equipment, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Northwest Medical Physics Equipment, Inc.” (first 1996, latest 2006), across 3 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 Northwest Medical Physics Equipment, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Northwest Medical Physics Equipment, Inc. is 204 days.
Which FDA product codes appear under Northwest Medical Physics Equipment, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 4); LNH (System, Nuclear Magnetic Resonance Imaging, 1); MUJ (System, Planning, Radiation Therapy Treatment, 1).
Next steps
- See all 6 Northwest Medical Physics Equipment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Northwest Medical Physics Equipment, 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.