FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL IMAGING SYSTEM
K Number: K954159
·
Decision Mar 19, 1996
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
16
Review Days
196
Basic Information
- Device Name
- DIGITAL IMAGING SYSTEM
- K Number
- K954159
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CAMTRONICS, LTD.
- Date Received
- September 5, 1995
- Decision Date
- March 19, 1996
- 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 CAMTRONICS, LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K021236 | SURGERY AND ACCESSORIES | Jul 17, 2002 | Substantially Equivalent |
| K013032 | PHYSIOLOG, SERIES 95000 | Jun 4, 2002 | Substantially Equivalent |
| K992666 | VIDEO PLUS SYSTEM, SERIES 95000 | Oct 13, 1999 | Substantially Equivalent |
| K992259 | ECHOCARDIOGRAPHY SYSTEM SERIES 95000 | Sep 8, 1999 | Substantially Equivalent |
| K990066 | CCD CAMERA, MODEL 9000 | Mar 17, 1999 | Substantially Equivalent |
| K955519 | ANALYTICAL REVIEW STATION | May 9, 1996 | Substantially Equivalent |
| K955232 | NT SERIES DIGITAL IMAGE MANAGER | Dec 11, 1995 | Substantially Equivalent |
| K953080 | DIGITAL IMAGING SYSTEM INTERFACE | Sep 28, 1995 | Substantially Equivalent |
| K945654 | NICOM DIGITAL IMAGE MANAGER | Feb 17, 1995 | Substantially Equivalent |
| K941979 | VIDEO PLUS WITH ANALYTICAL WORKSTATION | Aug 17, 1994 | Substantially Equivalent |