FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
K Number: K983678
·
Decision Jan 15, 1999
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
8
Review Days
87
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Basic Information
- Device Name
- ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
- K Number
- K983678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Instruments, Inc.
- Date Received
- October 20, 1998
- Decision Date
- January 15, 1999
- Product Code
- JAI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | FDA class 2 | Radiology |
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Other Clearances by Elekta Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955064 | SPETZLER TI 100 ANEURYSM CLIP | Oct 17, 1996 | Substantially Equivalent |
| K941823 | LEKSELL NEURO GENERATOR AND ACCESSORIES | Mar 22, 1996 | Substantially Equivalent |
| K946165 | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM | May 23, 1995 | Substantially Equivalent |
| K943468 | LEKSELL SURGIPLAN | Jan 20, 1995 | Substantially Equivalent |
| K932261 | ES-100 ACCESSORIES | Jan 7, 1994 | Substantially Equivalent |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | Sep 7, 1993 | Substantially Equivalent |
| K914808 | LEKSELL GAMMAPLAN (LGP) | Jan 23, 1992 | Substantially Equivalent |