Infimed, Inc.: FDA clearances and approvals
Infimed, Inc. has 14 FDA 510(k) clearances (first 1993, latest 2011), across 8 product codes in 1 review panel. Median 510(k) review time: 86 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (14)
Most recent Infimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112180 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) | OWB | 2011-08-10 | 13 |
| K111344 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) | OWB | 2011-06-10 | 29 |
| K103416 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM | OWB | 2011-03-17 | 115 |
| K101833 | INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | OWB | 2010-07-23 | 22 |
| K093066 | I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | OWB | 2010-03-16 | 167 |
| K012490 | ORION DIGITAL IMAGING SYSTEM | OWB | 2002-02-12 | 193 |
| K992392 | RTLX | MUH | 2000-03-31 | 256 |
| K992794 | STINGRAY DR, MODEL 1 | MQB | 1999-11-09 | 82 |
| K992575 | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 | LLZ | 1999-10-07 | 66 |
| K962422 | INFIMED DENTAL SYSTEM | EHD | 1997-09-11 | 444 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Infimed, Inc..
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 Infimed, Inc. have?
Infimed, Inc. has 14 FDA 510(k) clearances (first 1993, latest 2011), across 8 product codes in 1 review panel.
How long does FDA take to clear Infimed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Infimed, Inc.'s cleared 510(k)s is 86 days.
What devices does Infimed, Inc. make?
Its most frequent FDA product codes are OWB (Interventional Fluoroscopic X-Ray System, 6); LLZ (System, Image Processing, Radiological, 2); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Has Infimed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Infimed, Inc. Related entities may recall under other names.
Next steps
- See all 14 Infimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWB, Infimed, 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.