FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECTILINEAR SCANNER MODEL #187-270
K Number: K895799
·
Decision Feb 1, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
10
Review Days
126
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Basic Information
- Device Name
- RECTILINEAR SCANNER MODEL #187-270
- K Number
- K895799
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1300
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Atomic Products Corp.
- Date Received
- September 28, 1989
- Decision Date
- February 1, 1990
- Product Code
- IYW
- 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 |
|---|---|---|---|
| IYW | Scanner, Rectilinear, Nuclear | FDA class 1 | Radiology |
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|---|---|---|---|
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| K904623 | RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 | Nov 6, 1990 | Substantially Equivalent |
| K900851 | DIGITAL IMAGE ENHANCEMENT SYSTEM | May 11, 1990 | Substantially Equivalent |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | Feb 16, 1989 | 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 |