FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANX 14
K Number: K042397
·
Decision Oct 5, 2004
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
18
Review Days
33
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Basic Information
- Device Name
- SCANX 14
- K Number
- K042397
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Air Techniques, Inc.
- Date Received
- September 2, 2004
- Decision Date
- October 5, 2004
- 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 Air Techniques, Inc.
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|---|---|---|---|
| K191623 | ScanX Touch/ScanX Duo Touch | Aug 21, 2019 | Substantially Equivalent |
| 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 |
| 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 |