Elekta Instruments, Inc.
Tucker, GA, US
Elekta Instruments, Inc. appears in FDA device records in Tucker, GA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Elekta Instruments, Inc. between 1992 and 1999. The busiest year on record is 1995, with 2. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE | JAI | Substantially Equivalent | |
| K955064 | SPETZLER TI 100 ANEURYSM CLIP | HCH | Substantially Equivalent | |
| K941823 | LEKSELL NEURO GENERATOR AND ACCESSORIES | GXD | Substantially Equivalent | |
| K946165 | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM | HRS | Substantially Equivalent | |
| K943468 | LEKSELL SURGIPLAN | HAW | Substantially Equivalent | |
| K932261 | ES-100 ACCESSORIES | HWE | Substantially Equivalent | |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | GEY | Substantially Equivalent | |
| K914808 | LEKSELL GAMMAPLAN (LGP) | IWB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HCHClip, Aneurysm
- JAICouch, Radiation Therapy, Powered
- GXDGenerator, Lesion, Radiofrequency
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- GEYMotor, Surgical Instrument, Ac-Powered
- HAWNeurological Stereotaxic Instrument
- HRSPlate, Fixation, Bone
- IWBSystem, Radiation Therapy, Radionuclide
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain