FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kubtec DIGIVIEW 395
K Number: K151221
·
Decision Jun 23, 2015
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
10
Review Days
47
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Basic Information
- Device Name
- Kubtec DIGIVIEW 395
- K Number
- K151221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kub Technologies, Inc.
- Date Received
- May 7, 2015
- Decision Date
- June 23, 2015
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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|---|---|---|---|
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| K210957 | Kubec Xpert 80 Radiography System | Aug 31, 2021 | Substantially Equivalent |
| K210956 | Kubtec Mozart (XPERT42) | Aug 31, 2021 | Substantially Equivalent |
| K200756 | Kubtec Mozart Supra | Jun 12, 2020 | Substantially Equivalent |
| K183624 | Kubtec Mozart (Xpert42) | Jun 20, 2019 | Substantially Equivalent |
| K141539 | KUBTEC X250 | Oct 29, 2014 | Substantially Equivalent |
| K103348 | DIGIVIEW 250 | Oct 20, 2011 | Substantially Equivalent |
| K083510 | KUBTEC XPERT 20 | Jan 8, 2009 | Substantially Equivalent |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | Jun 20, 2007 | Substantially Equivalent |