Aktina Medical Physics Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Aktina Medical Physics Corp.” (first 1997, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 10 | 10 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 2 | 2 |
| JAI | Couch, Radiation Therapy, Powered | 1 | 1 |
Review panels
- Radiology (13)
Most recent Aktina Medical Physics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103616 | PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER | IYE | 2011-01-25 | 46 |
| K081935 | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 | IYE | 2008-10-07 | 92 |
| K040709 | PROTOS SOFTWARE | IYE | 2004-04-28 | 41 |
| K032248 | PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 | IYE | 2003-09-25 | 65 |
| K014081 | AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES | IYE | 2002-03-05 | 84 |
| K003330 | AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) | IYE | 2001-01-04 | 72 |
| K993522 | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT | JAI | 2000-01-10 | 84 |
| K991546 | AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD | IYE | 1999-07-30 | 88 |
| K990997 | AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER | IYE | 1999-06-22 | 89 |
| K974239 | AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM | IXI | 1998-02-10 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aktina Medical Physics Corp..
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.
- Aktina Medical Corporation (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aktina Medical Physics Corp.?
FDA lists 13 510(k) clearances under the applicant name “Aktina Medical Physics Corp.” (first 1997, latest 2011), across 3 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 Aktina Medical Physics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aktina Medical Physics Corp. is 84 days.
Which FDA product codes appear under Aktina Medical Physics Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 10); IXI (Block, Beam-Shaping, Radiation Therapy, 2); JAI (Couch, Radiation Therapy, Powered, 1).
Next steps
- See all 13 Aktina Medical Physics Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Aktina Medical Physics 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.