FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ArtPIX DRF
K Number: K202235
·
Decision Sep 3, 2020
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
12
Review Days
27
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Basic Information
- Device Name
- ArtPIX DRF
- K Number
- K202235
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cmt Medical Technologies, Ltd.
- Date Received
- August 7, 2020
- Decision Date
- September 3, 2020
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Cmt Medical Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K162224 | ArtPix Mobile EZ2GO | Sep 22, 2016 | Substantially Equivalent |
| K110849 | PRESTODR 4143 | Apr 26, 2011 | Substantially Equivalent |
| K103038 | DUET DRF | Mar 29, 2011 | Substantially Equivalent |
| K100400 | PRESTODR PORTABLE | Apr 22, 2010 | Substantially Equivalent |
| K080890 | SMARTSPOT PRIMAX | Apr 29, 2008 | Substantially Equivalent |
| K003438 | SMART RAD | Jul 3, 2001 | Substantially Equivalent |
| K001111 | PANORET, MODEL 1000A | Jul 7, 2000 | Substantially Equivalent |
| K991578 | SMARTSPOT 2000 | Jun 3, 1999 | Substantially Equivalent |
| K961140 | FLUOROPLUS CARDIAC TV | Sep 20, 1996 | Substantially Equivalent |
| K961307 | SMART SPOT | Jul 1, 1996 | Substantially Equivalent |