FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kubtec Mozart Supra
K Number: K200756
·
Decision Jun 12, 2020
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
26
Applicant Total
10
Review Days
80
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Basic Information
- Device Name
- Kubtec Mozart Supra
- K Number
- K200756
- 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
- March 24, 2020
- Decision Date
- June 12, 2020
- Product Code
- MWP
- 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 |
|---|---|---|---|
| MWP | Cabinet, X-Ray System | FDA class 2 | Radiology |
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Other Clearances by Kub Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Sep 20, 2021 | Substantially Equivalent |
| K210957 | Kubec Xpert 80 Radiography System | Aug 31, 2021 | Substantially Equivalent |
| K210956 | Kubtec Mozart (XPERT42) | Aug 31, 2021 | Substantially Equivalent |
| K183624 | Kubtec Mozart (Xpert42) | Jun 20, 2019 | Substantially Equivalent |
| K151221 | Kubtec DIGIVIEW 395 | Jun 23, 2015 | 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 |