510(k) K954565
- Device
- EXPLOR-X (AZTEH) HF
- Applicant
- CHICAGO X-RAY SYSTEMS, INC.
- 510(k) number
- K954565
- Product code
- EAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-27
- Date received
- 1995-10-02
- Regulation
- 872.1810
- Classification name
- Unit, X-ray, Intraoral
- Medical specialty
- Dental
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AL SOSA
- Address
- 219 Mayer Ave. Wheeling IL US 60090 60090
FDA Registration Numbers#
- 3011471624
- 3013511605
- 3015980207
- 1226003
- 3014398772
- 2424472
- 3010445368
- 3006529712
- 8020825
Source Documents#
Other 510(k) Records For Product Code EAP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113360 | MEDICAL IMAGE PROCESSING UNIT | Humanray Co,Ltd | 2012-02-07 |
| K102573 | PROVU (TM) DENTAL X-RAY SYSTEM | Advanced Image Science, Inc. | 2011-06-30 |
| K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2009-11-30 |
| K080738 | DENTRON SENSOR | Dentron Systems, LLC | 2008-05-13 |
| K052422 | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | Flow X-Ray Corp. | 2005-09-27 |
| K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | 2004-06-07 |
| K960819 | HELIODENT DS | Pelton & Crane Co. | 1996-03-29 |
| K960028 | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | Dentsply Intl. | 1996-03-01 |
| K953936 | ATLANTIS | Trophy Radiologie | 1995-12-28 |
| K951734 | LUMIX 70B | Emix U.S.A., Inc. | 1995-07-20 |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Trophy Radiologie | 1995-06-30 |
| K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | 1995-04-19 |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Chicago X-Ray Systems, Inc. | 1995-04-06 |
| K950030 | HELIODENT MD | Pelton & Crane Co. | 1995-02-03 |
| K934645 | RADWORKS | Radworks Corp. | 1994-08-17 |
Legacy Summary#
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FDA Review#
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