FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
K Number: K884312
·
Decision Feb 16, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
10
Review Days
126
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
- ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
- K Number
- K884312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1360
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Atomic Products Corp.
- Date Received
- October 13, 1988
- Decision Date
- February 16, 1989
- 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
Other Clearances by Atomic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915541 | SPECT TABLE, MODEL #056-760 | Jan 17, 1992 | Substantially Equivalent |
| K913055 | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | Sep 6, 1991 | Substantially Equivalent |
| K904187 | ECONOMY C-ARM TABLE, MODEL # 056-005 | Nov 29, 1990 | Substantially Equivalent |
| K904623 | RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 | Nov 6, 1990 | Substantially Equivalent |
| K900851 | DIGITAL IMAGE ENHANCEMENT SYSTEM | May 11, 1990 | Substantially Equivalent |
| K895799 | RECTILINEAR SCANNER MODEL #187-270 | Feb 1, 1990 | Substantially Equivalent |
| K871868 | VENTI-SCAN II | Apr 11, 1988 | Substantially Equivalent |
| K874332 | MRI STRETCHER | Jan 5, 1988 | Substantially Equivalent |
| K790835 | DYNAJECT | Jun 22, 1979 | Substantially Equivalent |