Standard Imaging, Inc.: FDA clearances and approvals
Standard Imaging, Inc. has 10 FDA 510(k) clearances (first 1992, latest 2010), across 6 product codes in 1 review panel. Median 510(k) review time: 46 days. openFDA lists 1 product recall by a recalling firm named Standard Imaging, Inc.
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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| KPT | Calibrator, Dose, Radionuclide | 2 | 2 |
| KPY | Shield, Protective, Personnel | 1 | 1 |
| LHO | Instrument, Quality-Assurance, Radiologic | 1 | 1 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 1 |
Review panels
- Radiology (10)
Most recent Standard Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103193 | DOSEVIEW 3D | IYE | 2010-12-27 | 59 |
| K082773 | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 | IYE | 2008-11-19 | 58 |
| K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 | JAQ | 2006-04-11 | 42 |
| K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | LHO | 2004-11-15 | 45 |
| K040688 | STANDARD IMAGING E.IMRT CALCULATOR | MUJ | 2004-05-11 | 56 |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | KPT | 2001-11-09 | 16 |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | KPT | 2000-09-28 | 16 |
| K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | JAQ | 2000-08-02 | 47 |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | KPY | 1994-03-16 | 37 |
| K922554 | STANDARD IMAGING HDR 1000 ION CHAMBER | JAQ | 1992-08-24 | 87 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-05-28.
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 Standard Imaging, Inc. have?
Standard Imaging, Inc. has 10 FDA 510(k) clearances (first 1992, latest 2010), across 6 product codes in 1 review panel.
How long does FDA take to clear Standard Imaging, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Standard Imaging, Inc.'s cleared 510(k)s is 46 days.
What devices does Standard Imaging, Inc. make?
Its most frequent FDA product codes are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 3); IYE (Accelerator, Linear, Medical, 2); KPT (Calibrator, Dose, Radionuclide, 2).
Has Standard Imaging, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Standard Imaging, Inc; the most recent began 2003-05-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Standard Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Standard Imaging, Inc.'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.