Soredex/PaloDEx Group OY. 2020. Download pico driver. 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: nahkelantie 160: tuusula 0430 0: FI 04300 Manufacturer Contact: terho turkumaki, manager nahkelantie 160: tuusula 04300 FI 04300. The Windows version was created by PaloDEx Group. Check out here for more information on PaloDEx Group. Click on www.palodexgroup.com to get more data about IAM on PaloDEx Group's website. IAM is typically set up in the C: Program Files (x86) PaloDEx Group IAM directory, however this location may vary a lot depending on the user's choice while.
-
| 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 |
|
| 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 |
|
|
| New Search | Submit an Adverse Event Report |
Drivers Palodex Group Oy Stock
Drivers Palodex Group Oy Llc
| Type of Device | ORTHOPANTOMOGRAPH OP300 |
|---|
| Manufacturer (Section D) | | PALODEX GROUP OY | | nahkelantie 160 | | tuusula 0430 0 | | FI 04300 |
|
|---|
| Manufacturer Contact | | terho turkumaki, manager | | nahkelantie 160 | | tuusula 04300 | | FI 04300 | | 503209113 |
|
|---|
| MDR Report Key | 2619735 |
|---|
| MDR Text Key | 2765165 |
|---|
| Report Number | 3005383085-2012-00001 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | MUH |
|---|
| Combination Product (Y/N) | N |
|---|
| Reporter Country Code | US |
|---|
| PMA/PMN Number | K093683 |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source | Manufacturer |
|---|
| Source Type | Company Representative |
|---|
| Reporter Occupation | DENTIST |
|---|
| Type of Report | Initial |
|---|
| Report Date | 06/05/2012,05/31/2012 |
|---|
| 1 Device Was Involved in the Event |
|---|
| 0 PatientS WERE Involved in the Event: |
|---|
| Date FDA Received | 06/05/2012 |
|---|
| Is This An Adverse Event Report? | No |
|---|
| Is This A Product Problem Report? | Yes |
|---|
| Device Operator | HEALTH PROFESSIONAL |
|---|
| Device Catalogue Number | 0.805.2001 |
|---|
| Was Device Available For Evaluation? | Yes |
|---|
| Date Returned to Manufacturer | 05/22/2012 |
|---|
| Is The Reporter A Health Professional? | Yes |
|---|
| Distributor Facility Aware Date | 05/17/2012 |
|---|
| Device Age | 9 mo |
|---|
| Date Manufacturer Received | 02/27/2012 |
|---|
| Was Device Evaluated By Manufacturer? | Yes |
|---|
| Date Device Manufactured | 08/01/2011 |
|---|
| Is The Device Single Use? | No |
|---|
| Is this a Reprocessed and Reused Single-Use Device? | No |
|---|
| Type of Device Usage | Unkown |
|---|
|
|