Scott Imaging Intl., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Scott Imaging Intl., Inc.” (first 1994, latest 1995), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IXQ | Table, Radiographic, Stationary Top | 1 | 1 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 1 |
Review panels
- Radiology (7)
Most recent Scott Imaging Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946260 | NTBS-1417, 1436, TBS-1417 | IXY | 1995-03-31 | 108 |
| K950041 | SII 360 APR | IZO | 1995-03-21 | 75 |
| K950040 | SII 525 APR | IZO | 1995-03-21 | 75 |
| K946262 | EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES | IXQ | 1995-02-15 | 64 |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | IYB | 1995-02-15 | 64 |
| K945709 | SII 525 MS | KPR | 1994-12-14 | 23 |
| K945708 | SII 360 MS | KPR | 1994-12-14 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Scott Imaging Intl., 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.
- Scott Laboratories, Inc. (16 510(k)s)
- Scott Health Care (9 510(k)s)
- Scott All-Sports, Inc. (2 510(k)s)
- Scott Paper Co. (2 510(k)s)
- The Scott & Fetzer Co. (1 510(k)s)
- Scott E Allen CP (1 510(k)s)
- Scott Feldman Dds & Norman Shapiro Dds (1 510(k)s)
- Scott Paper , Ltd. (1 510(k)s)
- Scott/Ross Designs, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scott Imaging Intl., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Scott Imaging Intl., Inc.” (first 1994, latest 1995), across 5 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 Scott Imaging Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scott Imaging Intl., Inc. is 64 days.
Which FDA product codes appear under Scott Imaging Intl., Inc.?
The most frequent FDA product codes under this applicant name are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 2); KPR (System, X-Ray, Stationary, 2); IXQ (Table, Radiographic, Stationary Top, 1).
Next steps
- See all 7 Scott Imaging Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Scott Imaging Intl., 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.