FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERPETT
K Number: K843366
·
Decision Nov 21, 1984
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
7
Review Days
85
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
- SUPERPETT
- K Number
- K843366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Scanditronix, Inc.
- Date Received
- August 28, 1984
- Decision Date
- November 21, 1984
- 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 Scanditronix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934303 | RFA A-300 | Aug 9, 1994 | Substantially Equivalent |
| K942092 | DPD-3 | Jul 29, 1994 | Substantially Equivalent |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Jan 4, 1993 | Substantially Equivalent |
| K914926 | SCANDIPLAN - VERSION 338 | May 28, 1992 | Substantially Equivalent |
| K904753 | DIOLASE | Nov 9, 1990 | Substantially Equivalent |
| K900434 | MM-22 MICROTRON, MM50 MICROTRON | Oct 23, 1990 | Substantially Equivalent |