Jamieson Film Co.: FDA clearances and approvals
Jamieson Film Co. has 6 FDA 510(k) clearances (first 1991, latest 1997), across 4 product codes in 1 review panel. Median 510(k) review time: 65 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 |
|---|---|---|---|
| IXX | Processor, Cine Film | 2 | 2 |
| IZI | System, X-Ray, Angiographic | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (6)
Most recent Jamieson Film Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970738 | KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT | IZI | 1997-05-07 | 68 |
| K971128 | CAP-35B III/CINE 275 | IXR | 1997-04-28 | 32 |
| K963334 | JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 | IXX | 1996-09-11 | 16 |
| K960043 | KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM | LLZ | 1996-03-27 | 84 |
| K953563 | VANGUARD XR-350 CINEANGIOGRAM PROJECTOR | IZI | 1995-10-05 | 66 |
| K913241 | JAMIESON JT-CRP CINE FILM PROCESSOR | IXX | 1991-09-24 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Jamieson Film Co..
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 Jamieson Film Co. have?
Jamieson Film Co. has 6 FDA 510(k) clearances (first 1991, latest 1997), across 4 product codes in 1 review panel.
How long does FDA take to clear Jamieson Film Co.'s 510(k)s?
The median time from FDA receipt to decision across Jamieson Film Co.'s cleared 510(k)s is 65 days.
What devices does Jamieson Film Co. make?
Its most frequent FDA product codes are IXX (Processor, Cine Film, 2); IZI (System, X-Ray, Angiographic, 2); IXR (Table, Radiographic, Tilting, 1).
Has Jamieson Film Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jamieson Film Co. Related entities may recall under other names.
Next steps
- See all 6 Jamieson Film Co. clearances with predicates and recalls
- Run predicate analysis for product code IXX, Jamieson Film Co.'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.