Scanx 14
FDA 510(k) K042397 · Air Techniques, Inc.
510(k) numberK042397
Submission
- Device name
- Scanx 14
- Applicant
- Air Techniques, Inc.
Hicksville, NY, US - Received
- September 2, 2004
- Decision date
- October 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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| K101289 | Scanx D5000 Series Scanner Model: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QBMQB · Traditional | 08/03/2010SE |
| K090169 | Spectra Fluorescence Caries Detection DeviceNBL · Traditional | 08/18/2009SE |
| K052271 | RinsendoNYL · Traditional | 05/26/2006SE |
| K050693 | AccentMUH · Traditional | 05/26/2005SE |
| K042266 | AcclaimNRD · Special | 08/31/2004SE |
| K031198 | Scanx 10MQB · Traditional | 06/20/2003SE |
| K024285 | A/T X-Ray 70EHD · Traditional | 04/16/2003SE |
| K013893 | ScanxMUH · Traditional | 02/01/2002SE |
Questions and answers
When was Scanx 14 cleared by the FDA?
Scanx 14 (K042397) received a 510(k) decision of Substantially Equivalent on October 5, 2004, 33 days after the submission was received.
What is the product code of K042397?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.