FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RALCO, MODEL R225 ACS
K Number: K091517
·
Decision Jul 14, 2009
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
6
Review Days
53
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Basic Information
- Device Name
- RALCO, MODEL R225 ACS
- K Number
- K091517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ralco S.R.L.
- Date Received
- May 22, 2009
- Decision Date
- July 14, 2009
- Product Code
- IZW
- 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 |
|---|---|---|---|
| IZW | Collimator, Automatic, Radiographic | FDA class 2 | Radiology |
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Other Clearances by Ralco S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K110856 | RALCO | Aug 10, 2011 | Substantially Equivalent |
| K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Dec 5, 2008 | Substantially Equivalent |
| K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | Nov 26, 2007 | Substantially Equivalent |
| K030487 | R 72 | Aug 1, 2003 | Substantially Equivalent |
| K946320 | R 302 | May 11, 1995 | Substantially Equivalent |