FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Supria True64
K Number: K171738
·
Decision Aug 18, 2017
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
795
Applicant Total
5
Review Days
67
Basic Information
- Device Name
- Supria True64
- K Number
- K171738
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Healthcare Americas Corporation
- Date Received
- June 12, 2017
- Decision Date
- August 18, 2017
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
FDA 510(k)
FDA Class 2
·Radiology
Philips iCT CT system
FDA 510(k)
FDA Class 2
·Radiology
CT Scanner TSX-501R/1 V11.1
FDA 510(k)
FDA Class 2
·Radiology
CardIQ Suite
FDA 510(k)
FDA Class 2
·Radiology
SCENARIA View Phase 5.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT
FDA 510(k)
FDA Class 2
·Radiology