FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
P-Cure Proton Beam Therapy System
K Number: K221996
·
Decision Mar 20, 2023
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
4
Review Days
257
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- P-Cure Proton Beam Therapy System
- K Number
- K221996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- P-Cure, Ltd.
- Date Received
- July 6, 2022
- Decision Date
- March 20, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHN), ordered by most recent decision date.
PROBEAT-CR
FDA 510(k)
FDA Class 2
·Radiology
ProBeam 360 Proton Therapy System v3.0
FDA 510(k)
FDA Class 2
·Radiology
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
FDA 510(k)
FDA Class 2
·Radiology
eMotus Respiratory Motion Management System
FDA 510(k)
FDA Class 2
·Radiology
P-Cure Proton Therapy System (PPTS)
FDA 510(k)
FDA Class 2
·Radiology