Modification to Computed Oral Radiology System
FDA 510(k) K093453 · Schick Technologies, Inc.
510(k) numberK093453
Submission
- Device name
- Modification to Computed Oral Radiology System
- Applicant
- Schick Technologies, Inc.
Long Island City, NY, US - Received
- November 5, 2009
- Decision date
- November 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K110768 | Computed Dental RadiographyMUH · Special | 04/20/2011SE |
| K072134 | Schick Computed Oral Radiology SystemMUH · Special | 11/02/2007SE |
| K053558 | Ceph, Model 4900MUH · Traditional | 02/17/2006SE |
| K041385 | Modification to Computed Oral Radiology SystemEAP · Special | 06/07/2004SE |
| K031291 | CDR Panx, Model 4792MUH · Traditional | 05/05/2003SE |
| K022953 | Modification to Computed Oral Radiology SystemMUH · Special | 10/02/2002SE |
| K001429 | Modification to Accudexa Bone DensitometerKGI · Special | 05/26/2000SE |
| K982661 | CDR - Pan Model 4700MQB · Traditional | 12/11/1998SE |
| K981124 | Accudexa Bone DensitometerKGI · Traditional | 06/04/1998SE |
| K971735 | Accudexa Bone DensitometerKGI · Traditional | 12/02/1997SE |
Questions and answers
When was Modification to Computed Oral Radiology System cleared by the FDA?
Modification to Computed Oral Radiology System (K093453) received a 510(k) decision of Substantially Equivalent on November 30, 2009, 25 days after the submission was received.
What is the product code of K093453?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.