| Device Type ID | 5258 |
| Device Name | System, X-ray, Extraoral Source, Digital |
| Regulation Description | Extraoral Source X-ray System. |
| Regulation Medical Specialty | Dental |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.1800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MUH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5258 |
| Device | System, X-ray, Extraoral Source, Digital |
| Product Code | MUH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extraoral Source X-ray System. |
| CFR Regulation Number | 872.1800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARESTREAM DENTAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CEFLA S.C. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTERPRISE INTERNATIONAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY SIRONA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTTIO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEXCOWIN CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DEXCOWIN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DUERR DENTAL AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDLEN IMAGING LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENORAY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HDX WILL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KAVO DENTAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NICAL SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OWANDY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PALODEX GROUP OY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PANORAMIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RAY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RAYENCE CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SOPRO - ACTEON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
TAKARA BELMONT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE YOSHIDA DENTAL MFG. CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TROPHY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VILLA SISTEMI MEDICALI S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZUMA DENTAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 8 |
Fire | 2 |
Electrical /Electronic Property Problem | 2 |
Device Alarm System | 2 |
Computer Software Problem | 1 |
Scanner | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Patient Data Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Smoking | 1 |
| Total Device Problems | 20 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Carestream Health, Inc. | II | Apr-03-2015 |
| 2 | Midmark Corp Dba Progeny Inc | II | Jan-25-2016 |
| 3 | Midmark Corp Dba Progeny Inc | II | Jan-09-2014 |
| 4 | Villa Radiology Systems LLC | II | Nov-06-2015 |