FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ULTRAPRO MODEL 98
K Number: K982563
·
Decision Oct 6, 1998
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
75
Basic Information
- Device Name
- ULTRAPRO MODEL 98
- K Number
- K982563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RAMSOFT, INC.
- Date Received
- July 23, 1998
- Decision Date
- October 6, 1998
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by RAMSOFT, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141881 | RAPIDRESULTS | Oct 31, 2014 | Substantially Equivalent |
| K052460 | POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE | Sep 21, 2005 | Substantially Equivalent |
| K031562 | RAMSOFT PACS, MODEL 3.0 | Aug 11, 2003 | Substantially Equivalent |
| K942917 | ULTRAPRO WORKSTATION | Nov 14, 1994 | Substantially Equivalent |