Elekta Instruments, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Elekta Instruments, Inc.” (first 1992, latest 1999), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 224 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Elekta, based on public ownership records.
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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| IWB | System, Radiation Therapy, Radionuclide | 1 | 1 |
| JAI | Couch, Radiation Therapy, Powered | 1 | 1 |
Review panels
- Neurology (3)
- Orthopedic (2)
- Radiology (2)
- General and Plastic Surgery (1)
Most recent Elekta Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE | JAI | 1999-01-15 | 87 |
| K955064 | SPETZLER TI 100 ANEURYSM CLIP | HCH | 1996-10-17 | 346 |
| K941823 | LEKSELL NEURO GENERATOR AND ACCESSORIES | GXD | 1996-03-22 | 709 |
| K946165 | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM | HRS | 1995-05-23 | 155 |
| K943468 | LEKSELL SURGIPLAN | HAW | 1995-01-20 | 185 |
| K932261 | ES-100 ACCESSORIES | HWE | 1994-01-07 | 262 |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | GEY | 1993-09-07 | 320 |
| K914808 | LEKSELL GAMMAPLAN (LGP) | IWB | 1992-01-23 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Elekta Instruments, 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.
- Elekta Instrument AB (35 510(k)s)
- Elekta , Ltd. (18 510(k)s)
- Elekta Solutions AB (15 510(k)s)
- Elekta, Inc. (4 510(k)s)
- Elekta Neuromag OY (4 510(k)s)
- Elekta Oncology Systems, Ltd. (4 510(k)s)
- Elekta Implants, SA (2 510(k)s)
- Elekta Inc. D/B/A Nucletron Corporation (1 510(k)s)
- Elekta Oncology Systems, Inc. (1 510(k)s)
- Elekta Radiosurgery, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Elekta Instruments, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Elekta Instruments, Inc.” (first 1992, latest 1999), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Elekta Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elekta Instruments, Inc. is 224 days.
Which FDA product codes appear under Elekta Instruments, Inc.?
The most frequent FDA product codes under this applicant name are GEY (Motor, Surgical Instrument, Ac-Powered, 1); GXD (Generator, Lesion, Radiofrequency, 1); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 8 Elekta Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEY, Elekta Instruments, 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.