FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LD2000 SERIES
K Number: K980565
·
Decision Mar 19, 1998
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- LD2000 SERIES
- K Number
- K980565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Scanning, Inc.
- Date Received
- February 13, 1998
- Decision Date
- March 19, 1998
- 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 |
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