FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMAGES-ON-CALL TELERADIOLOGY SYSTEM
K Number: K896095
·
Decision Feb 16, 1990
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
1
Review Days
119
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Basic Information
- Device Name
- IMAGES-ON-CALL TELERADIOLOGY SYSTEM
- K Number
- K896095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Devices & Services Co.
- Date Received
- October 20, 1989
- Decision Date
- February 16, 1990
- 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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