FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ScanX Touch/ScanX Duo Touch
K Number: K191623
·
Decision Aug 21, 2019
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
18
Review Days
64
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Basic Information
- Device Name
- ScanX Touch/ScanX Duo Touch
- K Number
- K191623
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Air Techniques, Inc.
- Date Received
- June 18, 2019
- Decision Date
- August 21, 2019
- Product Code
- MUH
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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Other Clearances by Air Techniques, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190949 | ScanX Barrier Envelopes | Jul 26, 2019 | Substantially Equivalent |
| K101289 | SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB | Aug 3, 2010 | Substantially Equivalent |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Aug 18, 2009 | Substantially Equivalent |
| K052271 | RINSENDO | May 26, 2006 | Substantially Equivalent |
| K050693 | ACCENT | May 26, 2005 | Substantially Equivalent |
| K042397 | SCANX 14 | Oct 5, 2004 | Substantially Equivalent |
| K042266 | ACCLAIM | Aug 31, 2004 | Substantially Equivalent |
| K031198 | SCANX 10 | Jun 20, 2003 | Substantially Equivalent |
| K024285 | A/T X-RAY 70 | Apr 16, 2003 | Substantially Equivalent |
| K013893 | SCANX | Feb 1, 2002 | Substantially Equivalent |