FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K Number: K031385
·
Decision Nov 10, 2003
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
4
Review Days
193
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Basic Information
- Device Name
- ANZAI AZ-733 RESPIRATORY GATING SYSTEM
- K Number
- K031385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anzai Medical Co., Ltd.
- Date Received
- May 1, 2003
- Decision Date
- November 10, 2003
- 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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