FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOTOPHONE MULTIVIEW
K Number: K931186
·
Decision Nov 22, 1993
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
6
Review Days
258
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Basic Information
- Device Name
- PHOTOPHONE MULTIVIEW
- K Number
- K931186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Image Data Corp.
- Date Received
- March 9, 1993
- Decision Date
- November 22, 1993
- Product Code
- LMD
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Image Data Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931292 | MULTIVIEW FOR WINDOWS | Jul 29, 1993 | Substantially Equivalent |
| K931060 | STATVIEW | May 20, 1993 | Substantially Equivalent |
| K922267 | PHOTOPHONE(R) MULTI VIEW(TM) | Feb 2, 1993 | Substantially Equivalent |
| K921527 | STATVIEW | Jun 24, 1992 | Substantially Equivalent |
| K896223 | PHOTOPHONE | Feb 12, 1990 | Substantially Equivalent |