FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
S9 DISPLAY SYSTEM
K Number: K874214
·
Decision Feb 22, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
52
Applicant Total
2
Review Days
129
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Basic Information
- Device Name
- S9 DISPLAY SYSTEM
- K Number
- K874214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- O.M.I. Oncology Microsystems, Inc.
- Date Received
- October 16, 1987
- Decision Date
- February 22, 1988
- Product Code
- JAD
- 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 |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | FDA class 2 | Radiology |
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Other Clearances by O.M.I. Oncology Microsystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883101 | DVS (OPTION 01) | Oct 7, 1988 | Substantially Equivalent |