FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
K Number: K961740
·
Decision Nov 14, 1996
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
6
Review Days
195
Basic Information
- Device Name
- KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
- K Number
- K961740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KODAK HEALTH IMAGING SYSTEMS, INC.
- Date Received
- May 3, 1996
- Decision Date
- November 14, 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 KODAK HEALTH IMAGING SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K961739 | KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT | Nov 14, 1996 | Substantially Equivalent |
| K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) | Aug 22, 1996 | Substantially Equivalent |
| K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY | Jun 7, 1996 | Substantially Equivalent |
| K951807 | KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER | Sep 13, 1995 | Substantially Equivalent |
| K951948 | KODAK XLS 8600 (PS) | Sep 13, 1995 | Substantially Equivalent |