Medical Image Processing Unit
FDA 510(k) K113360 · Humanray Co,Ltd
510(k) numberK113360
Submission
- Device name
- Medical Image Processing Unit
- Applicant
- Humanray Co,Ltd
Houston, TX, US - Received
- November 14, 2011
- Decision date
- February 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K951734 | Lumix 70BEAP · Traditional | Emix U.S.A., Inc. | 07/20/1995SE |
More from Emix U.S.A., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121132 | Ezsensor P Digital Intraoral SensorMQB · Special | 05/10/2012SE |
Questions and answers
When was Medical Image Processing Unit cleared by the FDA?
Medical Image Processing Unit (K113360) received a 510(k) decision of Substantially Equivalent on February 7, 2012, 85 days after the submission was received.
What is the product code of K113360?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.