FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
K Number: K983660
·
Decision Jul 14, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
2
Review Days
268
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Basic Information
- Device Name
- EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
- K Number
- K983660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Brainlab, Inc.
- Date Received
- October 19, 1998
- Decision Date
- July 14, 1999
- Product Code
- LHN
- 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
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Other Clearances by Brainlab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962939 | VECTORVISION | May 22, 1997 | Substantially Equivalent |