Portavision Medical, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Portavision Medical, LLC” (first 2007, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 69 days. Since 2017 the median was 64 days, against 62 days for all cleared 510(k)s in the same product codes. 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 | 1 | 152 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 90 |
| 2020 | 0 | — |
| 2021 | 2 | 53 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Portavision Medical, LLC took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 62 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| IXK | System, Imaging, X-Ray, Electrostatic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
Review panels
- Radiology (6)
Most recent Portavision Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212557 | Virtual C DRF-NEO Digital Imaging System | OWB | 2021-09-24 | 42 |
| K211191 | Virtual C DRF Digital Imaging System | OWB | 2021-06-24 | 64 |
| K191503 | MobileRay Pulse SE Digital Imaging System | OWB | 2019-09-04 | 90 |
| K133524 | PVMED DDR 2430T | MQB | 2014-04-16 | 152 |
| K083048 | NEORAY DR 2520 DIGITAL IMAGING SYSTEM | IZL | 2008-11-21 | 38 |
| K072766 | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | IXK | 2007-12-11 | 74 |
Recalls
openFDA lists no recalls under a recalling firm named Portavision Medical, LLC.
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 Portavision Medical, LLC?
FDA lists 6 510(k) clearances under the applicant name “Portavision Medical, LLC” (first 2007, latest 2021), across 4 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 Portavision Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Portavision Medical, LLC is 69 days. Since 2017: 64 days, versus 62 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Portavision Medical, LLC?
The most frequent FDA product codes under this applicant name are OWB (Interventional Fluoroscopic X-Ray System, 3); IXK (System, Imaging, X-Ray, Electrostatic, 1); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 6 Portavision Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code OWB, Portavision Medical, LLC'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.