Ziehm Imaging, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ziehm Imaging, Inc.” (first 2005, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
Review panels
- Radiology (7)
Most recent Ziehm Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092438 | ZIEHM SOLO | OWB | 2009-12-23 | 138 |
| K083545 | ZIEHM VISION RFD | OWB | 2009-05-15 | 168 |
| K073346 | ZIEHM VISION 2 | JAK | 2008-03-21 | 113 |
| K061534 | ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM | OWB | 2006-07-07 | 35 |
| K061310 | ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM | JAK | 2006-07-07 | 58 |
| K061203 | ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM | OWB | 2006-06-19 | 49 |
| K051064 | ZIEHM QUANTUM | OWB | 2005-05-26 | 30 |
Recalls
15 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2017-02-23.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ziehm Imaging GmbH (18 510(k)s)
- Ziehm International, Inc. (16 510(k)s)
- Ziehm-Orthoscan, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ziehm Imaging, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Ziehm Imaging, Inc.” (first 2005, latest 2009), across 2 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 Ziehm Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ziehm Imaging, Inc. is 58 days.
Which FDA product codes appear under Ziehm Imaging, Inc.?
The most frequent FDA product codes under this applicant name are OWB (Interventional Fluoroscopic X-Ray System, 5); JAK (System, X-Ray, Tomography, Computed, 2).
Next steps
- See all 7 Ziehm Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWB, Ziehm Imaging, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.