FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CELESTEION, PCA-9000A/2
K Number: K140651
·
Decision Jun 11, 2014
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
80
Review Days
90
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
- CELESTEION, PCA-9000A/2
- K Number
- K140651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toshibamedical Systems Corporation
- Date Received
- March 13, 2014
- Decision Date
- June 11, 2014
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPS), ordered by most recent decision date.
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
FDA 510(k)
FDA Class 2
·Radiology
uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
FDA 510(k)
FDA Class 2
·Radiology
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
FDA 510(k)
FDA Class 2
·Radiology
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
FDA 510(k)
FDA Class 2
·Radiology
AnyScan 3.0 NM Scanner Family
FDA 510(k)
FDA Class 2
·Radiology
Cartesion Prime (PCD-1000A/3) V10.21
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Toshibamedical Systems Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Apr 20, 2018 | Substantially Equivalent |
| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | Feb 23, 2018 | Substantially Equivalent |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | Jan 31, 2018 | Substantially Equivalent |
| K173382 | Vantage Galan 3T, V4.6 | Jan 26, 2018 | Substantially Equivalent |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Jan 11, 2018 | Substantially Equivalent |
| K172863 | Infinix-i, INFX-8000V, V7.0 | Dec 14, 2017 | Substantially Equivalent |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | Dec 12, 2017 | Substantially Equivalent |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0 | Oct 30, 2017 | Substantially Equivalent |
| K170832 | Ultimax-i, DREX-UI80 V1.60 | Jul 21, 2017 | Substantially Equivalent |
| K171597 | Vantage Elan 1.5T, V4.0 | Jul 21, 2017 | Substantially Equivalent |