FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Blue Phantom PT
K Number: K191821
·
Decision Jan 23, 2020
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
3
Review Days
199
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Basic Information
- Device Name
- Blue Phantom PT
- K Number
- K191821
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iba Dosimetry GmbH
- Date Received
- July 8, 2019
- Decision Date
- January 23, 2020
- Product Code
- LHN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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