FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOTOPHONE
K Number: K896223
·
Decision Feb 12, 1990
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
6
Review Days
105
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Basic Information
- Device Name
- PHOTOPHONE
- K Number
- K896223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Image Data Corp.
- Date Received
- October 30, 1989
- Decision Date
- February 12, 1990
- Product Code
- LMA
- 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 |
|---|---|---|---|
| LMA | Digitizer, Image, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMA), ordered by most recent decision date.
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Other Clearances by Image Data Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931186 | PHOTOPHONE MULTIVIEW | Nov 22, 1993 | Substantially Equivalent |
| 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 |