FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK PACS
K Number: K060055
·
Decision Feb 7, 2006
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
238
Review Days
29
Basic Information
- Device Name
- KODAK PACS
- K Number
- K060055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EASTMAN KODAK COMPANY
- Date Received
- January 9, 2006
- Decision Date
- February 7, 2006
- 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 EASTMAN KODAK COMPANY
| K Number | Device Name | ||
|---|---|---|---|
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 | Mar 31, 2006 | Substantially Equivalent |
| K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE | Mar 16, 2006 | Substantially Equivalent |
| K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM | Feb 8, 2006 | Substantially Equivalent |
| K053347 | KODAK CARESTREAM PACS | Jan 4, 2006 | Substantially Equivalent |
| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | Jun 21, 2005 | Substantially Equivalent |
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | Jun 1, 2005 | Substantially Equivalent |
| K042158 | KODAK MEDICAL IMAGER 300 | Sep 24, 2004 | Substantially Equivalent |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Sep 24, 2004 | Substantially Equivalent |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | May 24, 2004 | Substantially Equivalent |
| K040556 | TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY | Apr 7, 2004 | Substantially Equivalent |