Frantz Imaging, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Frantz Imaging, Inc.” (first 1987, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 33 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | 4 | 4 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
Review panels
- Radiology (5)
Most recent Frantz Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952485 | LASERNET IMAGE MANAGER/PRINT SERVER | LMA | 1995-11-24 | 178 |
| K921215 | LASERSTAR IMAGER | LMC | 1993-02-05 | 329 |
| K871959 | FRANTZ IMAGING COMPACT CAMERA | LMC | 1987-06-22 | 33 |
| K871958 | SPACEMISER 8-17 FILM RECORDER | LMC | 1987-06-22 | 33 |
| K871957 | SPACEMISER 8-10 FILM RECORDER | LMC | 1987-06-22 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Frantz Imaging, Inc..
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.
- Frantz Medical Development, Ltd. (5 510(k)s)
- Frantz Design, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Frantz Imaging, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Frantz Imaging, Inc.” (first 1987, latest 1995), 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 Frantz Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Frantz Imaging, Inc. is 33 days.
Which FDA product codes appear under Frantz Imaging, Inc.?
The most frequent FDA product codes under this applicant name are LMC (Camera, Multi Format, Radiological, 4); LMA (Digitizer, Image, Radiological, 1).
Next steps
- See all 5 Frantz Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMC, Frantz 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, 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.