FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTI-SCAN II
K Number: K871868
·
Decision Apr 11, 1988
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
47
Applicant Total
10
Review Days
334
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Basic Information
- Device Name
- VENTI-SCAN II
- K Number
- K871868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1390
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Atomic Products Corp.
- Date Received
- May 13, 1987
- Decision Date
- April 11, 1988
- Product Code
- IYT
- 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 |
|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | FDA class 2 | Radiology |
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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 |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | Feb 16, 1989 | Substantially Equivalent |
| K874332 | MRI STRETCHER | Jan 5, 1988 | Substantially Equivalent |
| K790835 | DYNAJECT | Jun 22, 1979 | Substantially Equivalent |