FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTALCAST
K Number: K860193
·
Decision Jan 30, 1986
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
10
Review Days
8
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Basic Information
- Device Name
- PORTALCAST
- K Number
- K860193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Diacor, Inc.
- Date Received
- January 22, 1986
- Decision Date
- January 30, 1986
- Product Code
- IXI
- 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 |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | FDA class 2 | Radiology |
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| K934566 | RADASSIST | Nov 3, 1993 | Substantially Equivalent |
| K930246 | MAMMORX | Jul 26, 1993 | Substantially Equivalent |
| K893398 | CENTRALITE BACKPOINTER | Aug 17, 1989 | Substantially Equivalent |
| K872489 | CENTRALITE | Jul 15, 1987 | Substantially Equivalent |