FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MasterX 800 Series
K Number: K230918
·
Decision Sep 1, 2023
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
9
Review Days
151
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Basic Information
- Device Name
- MasterX 800 Series
- K Number
- K230918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicatech USA
- Date Received
- April 3, 2023
- Decision Date
- September 1, 2023
- 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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Other Clearances by Medicatech USA
| K Number | Device Name | ||
|---|---|---|---|
| K190601 | MasteRad MX30 | Apr 25, 2019 | Substantially Equivalent |
| K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | Feb 6, 2015 | Substantially Equivalent |
| K130377 | KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | May 17, 2013 | Substantially Equivalent |
| K112132 | KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | Nov 18, 2011 | Substantially Equivalent |
| K102285 | KRYSTALRAD (ATAL8) | Jan 3, 2011 | Substantially Equivalent |
| K102284 | KRYSTALRAD 560 (FLAATZ 560) | Jan 3, 2011 | Substantially Equivalent |
| K082798 | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 | Oct 28, 2008 | Substantially Equivalent |
| K080582 | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA | May 15, 2008 | Substantially Equivalent |