.Decimal, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “.Decimal, Inc.” (first 2006, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 73 days. Since 2017 the median was 87 days, against 120 days for all cleared 510(k)s in the same product codes. 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 | 1 | 54 |
| 2013 | 1 | 90 |
| 2014 | 0 | — |
| 2015 | 2 | 76 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 140 |
| 2019 | 1 | 87 |
| 2020 | 0 | — |
| 2021 | 1 | 48 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name .Decimal, Inc. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 7 | 7 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 6 | 6 |
Review panels
- Radiology (13)
Most recent .Decimal, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211511 | decimal Bolus | MUJ | 2021-07-01 | 48 |
| K192554 | decimal3D | MUJ | 2019-12-13 | 87 |
| K173940 | Astroid Planning App | MUJ | 2018-05-15 | 140 |
| K151369 | .decimal p.d | MUJ | 2015-08-07 | 78 |
| K150547 | .decimal Astroid Dosimetry App | MUJ | 2015-05-15 | 73 |
| K132236 | .DECIMAL PROTON APERTURE | IXI | 2013-10-16 | 90 |
| K123015 | .DECIMAL PHOTON BLOCK | IXI | 2012-11-21 | 54 |
| K111759 | .DECIMAL ELECTRON APERTURE | IXI | 2011-09-09 | 79 |
| K091911 | BOLUS COMPENSATOR | IXI | 2009-07-21 | 26 |
| K083672 | P.D SOFTWARE | MUJ | 2009-04-13 | 123 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named .Decimal, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under .Decimal, Inc.?
FDA lists 13 510(k) clearances under the applicant name “.Decimal, Inc.” (first 2006, latest 2021), 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 .Decimal, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name .Decimal, Inc. is 73 days. Since 2017: 87 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under .Decimal, Inc.?
The most frequent FDA product codes under this applicant name are MUJ (System, Planning, Radiation Therapy Treatment, 7); IXI (Block, Beam-Shaping, Radiation Therapy, 6).
Next steps
- See all 13 .Decimal, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUJ, .Decimal, 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.