Northwest Medical Physics Center: FDA clearances and approvals
Northwest Medical Physics Center has 6 FDA 510(k) clearances (first 1991, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time: 287 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 4 | 4 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (6)
Most recent Northwest Medical Physics Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953227 | CASPER | IXI | 1995-11-22 | 140 |
| K941118 | HEAD IMMOBILIZATION APPARATUS | IYE | 1995-08-25 | 536 |
| K933117 | IORT SYSTEM | IYE | 1995-02-16 | 601 |
| K944613 | SHOULDER RETRACTOR | KPR | 1995-01-18 | 120 |
| K930182 | RADIATION TREATMENT FOR CANCER PATIENTS | IYE | 1994-01-05 | 356 |
| K904908 | STEREOTACTIC IRRADIATION SYSTEM | IYE | 1991-06-06 | 218 |
Recalls
openFDA lists no recalls under a recalling firm named Northwest Medical Physics Center.
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.
Frequently asked questions
How many FDA 510(k) clearances does Northwest Medical Physics Center have?
Northwest Medical Physics Center has 6 FDA 510(k) clearances (first 1991, latest 1995), across 3 product codes in 1 review panel.
How long does FDA take to clear Northwest Medical Physics Center's 510(k)s?
The median time from FDA receipt to decision across Northwest Medical Physics Center's cleared 510(k)s is 287 days.
What devices does Northwest Medical Physics Center make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 4); IXI (Block, Beam-Shaping, Radiation Therapy, 1); KPR (System, X-Ray, Stationary, 1).
Has Northwest Medical Physics Center had device recalls?
openFDA lists no recalls under a recalling firm name matching Northwest Medical Physics Center. Related entities may recall under other names.
Next steps
- See all 6 Northwest Medical Physics Center clearances with predicates and recalls
- Run predicate analysis for product code IYE, Northwest Medical Physics Center'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.