FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MAMMOSITE II RADIATION THERAPY SYSTEM
K Number: K091378
·
Decision Jul 2, 2009
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
116
Review Days
52
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Basic Information
- Device Name
- MAMMOSITE II RADIATION THERAPY SYSTEM
- K Number
- K091378
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- May 11, 2009
- Decision Date
- July 2, 2009
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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