PaloDEx Group is a Finnish company making equipment for dental radiography. Since 2009, the company is owned by the American Danaher Corporation.
PALODEX GROUP OY: nahkelantie 160: tuusula 0430 0: FI 04300 Manufacturer Contact: terho turkumaki, manager nahkelantie 160: tuusula 04300 FI 04300. Soredex Palodex Group Oy at NAHKELANTIE 160 TUUSULA FI. Find their customers, contact information, and details on 143 shipments. Soredex/PaloDEx Group OY. 2020. 12.04 ISO 13485 & 9001 Certificate. Soredex/PaloDEx Group OY. 2019. 02.28 ISO Certificate. Soredex/PaloDEx Group OY. 2021. 01.31 EC Certificate. Dental Imaging Technologies Corporation. Dental Imaging Technologies Corporation. Palodex Group Oy designs, manufactures, sells and markets high-quality dentomaxillofacial and ENT imaging equipment and solutions for demanding international customers. We are a part of the global Kavo Kerr Group, belonging to NYSE listed Danaher Corporation The roots of Palodex are firmly in Finland and Finnish imaging knowhow, and our.
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The company was started in 1964 as Palomex Oy to manufacture the Orthopantomograph®, a device for making panoramic radiographs invented by Finnish professor Yrjö Paatero. The device made possible to take a panoramic X-ray dental image in a single exposure.[1]
Palomex Oy was acquired by the Finnish optical and medical equipment company Instrumentarium in 1977. Some of the company’s operations formed a new company Soredex Oy, which was merged with the Orion Group in 1981. Palomex was renamed as Instrumentarium Imaging in 1988. In 2001, Instrumentarium acquired Soredex and now possessed two strong brands in dental imaging.[1]
GE Healthcare acquired Instrumentarium in 2003. Two years later, GE sold its dental imaging operations which were formed into a separate company, PaloDEx Group Oy. In 2009, the company was acquired by Danaher Corporation.[2] The company’s product families now include Instrumentarium Dental and Soredex.[1]
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Sources[edit]
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- ^ abcThe PaloDEx Group’s historyArchived 2013-10-16 at the Wayback Machine
- ^Fred Michmershuizen: Danaher acquires PaloDEx, Dental Tribune, Oct. 23, 2009
Retrieved from 'https://en.wikipedia.org/w/index.php?title=PaloDEx&oldid=922490694'
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| 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards |
| CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC |
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| PALODEX GROUP OY GXDP-700 ORTHOPANTOMOGRAPH OP300 | Back to Search Results |
| | Catalog Number 0.805.2001 | | Device Problem Fire (1245) | | Patient Problem No Information (3190) | | Event Date 02/27/2012 | | Event Type Malfunction | | Event Description | During a routine follow-up phone call on (b)(6) 2012, to request additional information about the original complaint which was for 'smell of smoke,' the office reported that the unit caught fire. | | Manufacturer Narrative | The reported symptom of circuit failure and or burning circuitry could not be duplicated nor confirmed. Visual/physical examination accompanied by olfactory odor detection yielded no evidence of failed circuitry or components consistent with the reported symptoms of burning. A failure of the display was found. The reported symptom of gui display failure was confirmed. No pt involvement. | | Search Alerts/Recalls |
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| New Search | Submit an Adverse Event Report |
| Type of Device | ORTHOPANTOMOGRAPH OP300 |
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| Manufacturer (Section D) | | PALODEX GROUP OY | | nahkelantie 160 | | tuusula 0430 0 | | FI 04300 |
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| Manufacturer Contact | | terho turkumaki, manager | | nahkelantie 160 | | tuusula 04300 | | FI 04300 | | 503209113 |
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| MDR Report Key | 2619735 |
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| MDR Text Key | 2765165 |
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| Report Number | 3005383085-2012-00001 |
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| Device Sequence Number | 1 |
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| Product Code | MUH |
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| Combination Product (Y/N) | N |
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| Reporter Country Code | US |
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| PMA/PMN Number | K093683 |
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| Number of Events Reported | 1 |
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| Summary Report (Y/N) | N |
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| Report Source | Manufacturer |
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| Source Type | Company Representative |
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| Reporter Occupation | DENTIST |
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| Type of Report | Initial |
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| Report Date | 06/05/2012,05/31/2012 |
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| 1 Device Was Involved in the Event |
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| 0 PatientS WERE Involved in the Event: |
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| Date FDA Received | 06/05/2012 |
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| Is This An Adverse Event Report? | No |
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| Is This A Product Problem Report? | Yes |
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| Device Operator | HEALTH PROFESSIONAL |
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| Device Catalogue Number | 0.805.2001 |
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| Was Device Available For Evaluation? | Yes |
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| Date Returned to Manufacturer | 05/22/2012 |
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| Is The Reporter A Health Professional? | Yes |
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| Distributor Facility Aware Date | 05/17/2012 |
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| Device Age | 9 mo |
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| Date Manufacturer Received | 02/27/2012 |
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| Was Device Evaluated By Manufacturer? | Yes |
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| Date Device Manufactured | 08/01/2011 |
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| Is The Device Single Use? | No |
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| Is this a Reprocessed and Reused Single-Use Device? | No |
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| Type of Device Usage | Unkown |
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