Almana Medical Imaging: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Almana Medical Imaging” (first 2007, latest 2010), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 107 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 3 | 3 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (5)
Most recent Almana Medical Imaging 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100001 | MOBIVISION | MQB | 2010-06-25 | 172 |
| K082064 | RADVISION ET DIAGNOSTIC X-RAY SYSTEM | KPR | 2008-08-22 | 32 |
| K080847 | RFVISION, MODEL 9.9D | OWB | 2008-08-06 | 133 |
| K080614 | DR VISION NEO, DR VISION DOU | KPR | 2008-06-20 | 107 |
| K072659 | RAD VISION, MODELS E AND EU | KPR | 2007-11-15 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Almana Medical Imaging.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Almana Medical Imaging?
FDA lists 5 510(k) clearances under the applicant name “Almana Medical Imaging” (first 2007, latest 2010), 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 Almana Medical Imaging?
The median time from FDA receipt to decision across 510(k)s cleared under the name Almana Medical Imaging is 107 days.
Which FDA product codes appear under Almana Medical Imaging?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 3); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 1); OWB (Interventional Fluoroscopic X-Ray System, 1).
Next steps
- See all 5 Almana Medical Imaging clearances with predicates and recalls
- Run predicate analysis for product code KPR, Almana Medical Imaging'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.