FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM
K Number: K860606
·
Decision Mar 20, 1986
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM
- K Number
- K860606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Bionix Corp.
- Date Received
- February 19, 1986
- Decision Date
- March 20, 1986
- 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 Bionix Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K852039 | FLEX-LOOP FLEXIBLE EAR CORETTE | Jun 11, 1985 | Substantially Equivalent |