FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
K Number: K180601
·
Decision Nov 2, 2018
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
13
Review Days
240
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Basic Information
- Device Name
- Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
- K Number
- K180601
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Villa Sistemi Medicali S.P.A.
- Date Received
- March 7, 2018
- Decision Date
- November 2, 2018
- Product Code
- OAS
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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Other Clearances by Villa Sistemi Medicali S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | Jul 6, 2017 | Substantially Equivalent |
| K130109 | ENDOGRAPH DC | Aug 1, 2013 | Substantially Equivalent |
| K111152 | ROTOGRAPH EVO 3D | Jul 22, 2011 | Substantially Equivalent |
| K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | May 18, 2009 | Substantially Equivalent |
| K080859 | DRF 4343 | Jun 4, 2008 | Substantially Equivalent |
| K050190 | APOLLO | Mar 25, 2005 | Substantially Equivalent |
| K030634 | ENDOS DC | Jul 21, 2003 | Substantially Equivalent |
| K030185 | ENDOS AC/ACP | Mar 11, 2003 | Substantially Equivalent |
| K002432 | STRATO X | Sep 1, 2000 | Substantially Equivalent |
| K000412 | VISION R/F TILTING TABLE | Apr 24, 2000 | Substantially Equivalent |