FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADCAL MODEL 4046 RADIONUCLIDE CALIBR
K Number: K841785
·
Decision Jul 16, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
4
Review Days
77
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
- RADCAL MODEL 4046 RADIONUCLIDE CALIBR
- K Number
- K841785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1360
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radcal Corp.
- Date Received
- April 30, 1984
- Decision Date
- July 16, 1984
- Product Code
- KPT
- 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 |
|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPT), ordered by most recent decision date.
CRC PC Smart Chamber K1
FDA 510(k)
FDA Class 2
·Radiology
CRC-77tHR
FDA 510(k)
FDA Class 2
·Radiology
Veenstra Instruments VDC-506 Dose Calibrator
FDA 510(k)
FDA Class 2
·Radiology
CRC PC WITH SMART CHAMBER
FDA 510(k)
FDA Class 2
·Radiology
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
FDA 510(k)
FDA Class 2
·Radiology
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
FDA 510(k)
FDA Class 2
·Radiology