Intrex
FDA 510(k) K833241 · Pennwalt Corp.
510(k) numberK833241
Submission
- Device name
- Intrex
- Applicant
- Pennwalt Corp.
Mchenry, IL, US - Received
- August 22, 1983
- Decision date
- October 28, 1983
- 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 |
More from Chicago X-Ray Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801860 | S.S. White-Pennwalt Renew Calcium HydroxEJK · Traditional | 10/10/1980SE |
| K801274 | S.S. White-Pennwalt Prelude Pit SealantEBC · Traditional | 06/09/1980SE |
| K800133 | Panorex II Dental X-Ray UnitEHD · Traditional | 03/03/1980SE |
| K800063 | XR-710EAP · Traditional | 03/03/1980SE |
| K780981 | Portable Pneumatic Calibrator 65-150BXX · Traditional | 08/02/1978SE |
Questions and answers
When was Intrex cleared by the FDA?
Intrex (K833241) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 67 days after the submission was received.
What is the product code of K833241?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.