Mdt/Castle Model HDX Dental X-Ray Machine
FDA 510(k) K896024 · Mdt Diagnostic Co.
510(k) numberK896024
Submission
- Device name
- Mdt/Castle Model HDX Dental X-Ray Machine
- Applicant
- Mdt Diagnostic Co.
Rochester, NY, US - Received
- October 16, 1989
- Decision date
- January 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113360 | Medical Image Processing UnitEAP · Special | Humanray Co,Ltd | 02/07/2012SE |
| K102573 | Provu (TM) Dental X-Ray SystemEAP · Traditional | Advanced Image Science, Inc. | 06/30/2011SE |
| 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 |
Questions and answers
When was Mdt/Castle Model HDX Dental X-Ray Machine cleared by the FDA?
Mdt/Castle Model HDX Dental X-Ray Machine (K896024) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 98 days after the submission was received.
What is the product code of K896024?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.