FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMATION MODEL 9410 NETWORK INTERFACE
K Number: K973303
·
Decision Nov 25, 1997
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
5
Review Days
83
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Basic Information
- Device Name
- IMATION MODEL 9410 NETWORK INTERFACE
- K Number
- K973303
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imation Corp.
- Date Received
- September 3, 1997
- Decision Date
- November 25, 1997
- Product Code
- LMD
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Imation Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | Jan 25, 1999 | Substantially Equivalent |
| K980722 | TRIMAX RADIOGRAPHIC CASSETTE | Mar 23, 1998 | Substantially Equivalent |
| K972163 | IMATION SE-196 LASER IMAGER | Sep 5, 1997 | Substantially Equivalent |
| K962750 | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR | Aug 21, 1996 | Substantially Equivalent |