Eva Digital Dental X-Ray System
FDA 510(k) K030647 · Afp Imaging Corp.
510(k) numberK030647
Submission
- Device name
- Eva Digital Dental X-Ray System
- Applicant
- Afp Imaging Corp.
North Attleboro, MA, US - Received
- February 28, 2003
- Decision date
- March 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260367 | Portable Dental X-ray System Model PDX novaEHD · Traditional | PDX Co., Ltd. | 05/27/2026SE |
| K253864 | NOMAD Pro 3EHD · Traditional | Dental Imaging Technologies Corporation | 03/20/2026SE |
| K252110 | Dental X-RAY Unit (AJX200)EHD · Traditional | Guangzhou Ajax Medical Equipment Co., Ltd. | 03/12/2026SE |
| K254018 | Portable Dental X-ray Device (GT-1)EHD · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 02/19/2026SE |
| K252909 | Diagnostic X-Ray Equipment Model POCT22EHD · Traditional | Ningbo Runyes Medical Instrument Co., Ltd. | 02/03/2026SE |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special | Guilin Woodpecker Medical Instrument Co., Ltd. | 09/04/2025SE |
| K242185 | Rextar ProEHD · Traditional | Raypia Co., Ltd. | 12/04/2024SE |
| K242591 | XERO-alphaEHD · Traditional | DRTECH Corporation | 11/01/2024SE |
| K241963 | WerayEHD · Traditional | Picopack Co., Ltd. | 07/30/2024SE |
| K241305 | LifeRay Intraoral Handheld X-ray SystemEHD · Traditional | Lucas Lifecare | 07/05/2024SE |
More from Lucas Lifecare
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 |
| K930761 | Image-X 70 Intraoral X-Ray SystemEAP · Traditional | 05/25/1993SE |
| K925684 | Olymp-X,X-Ray GeneratorIZO · Traditional | 02/02/1993SE |
Questions and answers
When was Eva Digital Dental X-Ray System cleared by the FDA?
Eva Digital Dental X-Ray System (K030647) received a 510(k) decision of Substantially Equivalent on March 20, 2003, 20 days after the submission was received.
What is the product code of K030647?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.