FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACS SOFTWARE SOLUTION 2003
K Number: K033624
·
Decision Dec 15, 2003
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
48
Review Days
27
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Basic Information
- Device Name
- PACS SOFTWARE SOLUTION 2003
- K Number
- K033624
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon USA, Inc.
- Date Received
- November 18, 2003
- Decision Date
- December 15, 2003
- 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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| K023586 | DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS | Nov 5, 2002 | Substantially Equivalent |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Jan 2, 2002 | Substantially Equivalent |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Jun 21, 2000 | Substantially Equivalent |
| K992547 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 | Oct 13, 1999 | Substantially Equivalent |
| K981556 | CANON X-RAY DIGITAL CAMERA CXDI-11 | Nov 4, 1998 | Substantially Equivalent |
| K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | May 6, 1998 | Substantially Equivalent |