Radx System
by Electro Medical Systems, Inc.
510(k) K965203
Radx System is a Class II device made by Electro Medical Systems, Inc., cleared under FDA 510(k) K965203 on 17 Mar 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965203 | Date17 Mar 1997 | StatusActive |
Official records
- FDA 510(k) database K965203
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).
- JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 by Progeny, Inc.
- DIMAX 2 by Planmeca Oy
- ORTHOCEPH OC100 by Instrumentarium Corp.
- EVA DIGITAL DENTAL X-RAY SYSTEM by Afp Imaging Corp.
- PORTABLE X-RAY SYSTEM (MODEL:EXARO, XRAY2GO) by OSSTEM IMPLANT CO.,LTD
- Orthophos E 6707488 by SIRONA Dental Systems GmbH
- CORIX 70 PLUS-USV by Coramex, S.A.
- PORTABLE DENTAL X-RAY UNIT MODEL 4000 by Home/Office Dental, Inc.
- ENDOS DC by VILLA SISTEMI MEDICALI S.P.A.
- Hand-held Dental X-ray System (HyperLight-M) by CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.