FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
K Number: K012373
·
Decision Aug 9, 2001
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
50
Applicant Total
2
Review Days
14
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Basic Information
- Device Name
- LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
- K Number
- K012373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1850
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ferrania S.P.A.
- Date Received
- July 26, 2001
- Decision Date
- August 9, 2001
- Product Code
- IXA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | FDA class 2 | Radiology |
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Other Clearances by Ferrania S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K013395 | LIFEJET VIDEO LINK | Oct 30, 2001 | Substantially Equivalent |