Fischer Imaging Corp.: FDA filings under this applicant name
FDA lists 69 510(k) clearances under the applicant name “Fischer Imaging Corp.” (first 1981, latest 2004), across 17 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 22 | 22 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 10 | 10 |
| IXR | Table, Radiographic, Tilting | 8 | 8 |
| IZH | System, X-Ray, Mammographic | 8 | 8 |
| IYB | Tube Mount, X-Ray, Diagnostic | 5 | 5 |
| IZI | System, X-Ray, Angiographic | 4 | 4 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| IXL | Device, Spot-Film | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Plus 7 more product codes.
Review panels
- Radiology (69)
Most recent Fischer Imaging Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042095 | MAMMOTEST | IZH | 2004-10-29 | 87 |
| K021113 | MAMMOPATH | MWP | 2002-06-13 | 69 |
| K981414 | LC POSITIONER | JAA | 1998-07-16 | 87 |
| K973400 | MAMMOTEST ADAPTER DRIVER | IZH | 1997-11-10 | 62 |
| K964806 | MD-1835 | IXL | 1997-03-04 | 95 |
| K961207 | EP-X BIPLANE | JAA | 1996-08-20 | 146 |
| K961022 | TANGENT VI TABLE | IXR | 1996-05-03 | 50 |
| K950291 | DIGITAL 625HF | IZO | 1995-03-23 | 57 |
| K945619 | ATHENA HFX | IZH | 1995-03-23 | 128 |
| K944150 | MICRO X-65 HF | IZO | 1994-09-16 | 22 |
59 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2006-03-27.
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.
- Fischer Industries, Inc. (3 510(k)s)
- Fischer Medical (1 510(k)s)
- Fischer Medical Technologies, Inc. (1 510(k)s)
- Fischer Surgical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fischer Imaging Corp.?
FDA lists 69 510(k) clearances under the applicant name “Fischer Imaging Corp.” (first 1981, latest 2004), across 17 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 Fischer Imaging Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fischer Imaging Corp. is 66 days.
Which FDA product codes appear under Fischer Imaging Corp.?
The most frequent FDA product codes under this applicant name are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 22); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 10); IXR (Table, Radiographic, Tilting, 8).
Next steps
- See all 69 Fischer Imaging Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Fischer Imaging Corp.'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.