FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANMASTER DX
K Number: K953117
·
Decision Jan 18, 1996
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
5
Review Days
199
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Basic Information
- Device Name
- SCANMASTER DX
- K Number
- K953117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howtek, Inc.
- Date Received
- July 3, 1995
- Decision Date
- January 18, 1996
- 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
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Other Clearances by Howtek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021949 | FULCRUM | Aug 12, 2002 | Substantially Equivalent |
| K973081 | DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) | Nov 5, 1997 | Substantially Equivalent |
| K972191 | DIGITIZER DIRECTOR (HSC025-01) | Sep 8, 1997 | Substantially Equivalent |
| K970908 | HOWTEK 960 | May 20, 1997 | Substantially Equivalent |