Image-X 70 Intraoral X-Ray System
FDA 510(k) K930761 · Afp Imaging Corp.
510(k) numberK930761
Submission
- Device name
- Image-X 70 Intraoral X-Ray System
- Applicant
- Afp Imaging Corp.
Elmsford, NY, US - Received
- February 12, 1993
- Decision date
- May 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K113360 | Medical Image Processing UnitEAP · Special | Humanray Co,Ltd | 02/07/2012SE |
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| K093453 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 11/30/2009SE |
| K080738 | Dentron SensorEAP · Traditional | Dentron Systems, LLC | 05/13/2008SE |
| K052422 | The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special | Flow X-Ray Corp. | 09/27/2005SE |
| K041385 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 06/07/2004SE |
| K960819 | Heliodent DSEAP · Traditional | Pelton & Crane Co. | 03/29/1996SE |
| K960028 | Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional | Dentsply Intl. | 03/01/1996SE |
| K953936 | AtlantisEAP · Traditional | Trophy Radiologie | 12/28/1995SE |
| K954565 | Explor-X (Azteh) HFEAP · Traditional | Chicago X-Ray Systems, Inc. | 10/27/1995SE |
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| 510(k) | Device | Decision |
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| K123419 | Eva Select Digital Dental Imaging SystemMUH · Special | 12/27/2012SE |
| K072357 | Newtom VG Computed Tomography X-Ray SystemMUH · Special | 09/18/2007SE |
| K041120 | Ev Apan Digital, Model K1VSM2000MUH · Traditional | 08/30/2004SE |
| K030647 | Eva Digital Dental X-Ray SystemEHD · Special | 03/20/2003SE |
| K014144 | Extoral/Tescera Glazing Resin, Model T-1804EBF · Traditional | 02/07/2002SE |
| K013176 | Modification to: Sens-A-Ray System with Proimage SoftwareEHD · Special | 10/16/2001SE |
| K974619 | Scanaray/Cd-Dent Advanced Computerized X-Ray SystemLMA · Traditional | 02/25/1998SE |
| K950288 | Autolaser Multi Format CameraLMC · Traditional | 04/04/1995SE |
| K925885 | Afp 17 X 4 Automatic Film ProcessorIXW · Traditional | 06/09/1993SE |
| K925684 | Olymp-X,X-Ray GeneratorIZO · Traditional | 02/02/1993SE |
Questions and answers
When was Image-X 70 Intraoral X-Ray System cleared by the FDA?
Image-X 70 Intraoral X-Ray System (K930761) received a 510(k) decision of Substantially Equivalent on May 25, 1993, 102 days after the submission was received.
What is the product code of K930761?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.