FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
C.CAM-AC
K Number: K051460
·
Decision Jun 15, 2005
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
6
Review Days
12
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
- C.CAM-AC
- K Number
- K051460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Danish Diagnostic Development A/S
- Date Received
- June 3, 2005
- Decision Date
- June 15, 2005
- Product Code
- KPS
- 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 |
|---|---|---|---|
| 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 Danish Diagnostic Development A/S
| K Number | Device Name | ||
|---|---|---|---|
| K081829 | CAPIMAGE | Jul 11, 2008 | Substantially Equivalent |
| K040616 | CARDIOMD-AC | Mar 24, 2004 | Substantially Equivalent |
| K031825 | C.CAM | Jun 20, 2003 | Substantially Equivalent |
| K011611 | CARDIOCAM MODEL 9CSY0799 | Jun 8, 2001 | Substantially Equivalent |
| K001888 | UNICORN MODEL SYS0630 | Jun 30, 2000 | Substantially Equivalent |