Unit, X-Ray, Extraoral With Timer
Regulation 872.1800
6510(k)s in 12 months (191 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in EHD
| Company | 510(k)s | Recalls |
|---|---|---|
| Planmeca Oy | 14 | 0 |
| Digimed Co., Ltd. | 6 | 1 |
| Gendex Dental Systems | 1 | 6 |
| Villa Sistemi Medicali S.P.A. | 7 | 0 |
| Trophy Radiologie | 6 | 0 |
| VATECH Co., Ltd. | 6 | 0 |
| Aribex | 3 | 2 |
| Dentsply Intl. | 4 | 0 |
| Gendex Corp. | 3 | 1 |
| Instrumentarium Corp. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2003 | K030647 | EVA DIGITAL DENTAL X-RAY SYSTEM Afp Imaging Corp. | EHD |
| Mar 11, 2003 | K030185 | ENDOS AC/ACP Villa Sistemi Medicali S.P.A. | EHD |
| Oct 9, 2002 | K022630 | MODIFICATION TO FOCUS Instrumentarium Corp. | EHD |
| Jun 7, 2002 | K021378 | PORTABLE HDX INTRAORAL X-RAY Dentalez Group | EHD |
| May 3, 2002 | K021245 | DEGOTZEN SYNCHRO The Gotzen Group, Inc. | EHD |
| Feb 15, 2002 | K011147 | CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT) Cavitat Medical Technologies, Inc. | EHD |
| Feb 4, 2002 | K013955 | VERAVIEWEPOCS, MODEL VE J. Morita USA, Inc. | EHD |
| Feb 1, 2002 | K020070 | JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 Progeny, Inc. | EHD |
| Oct 16, 2001 | K013176 | MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE Afp Imaging Corp. | EHD |
| Aug 9, 2001 | K012355 | IMAGE-X SYSTEM Tg Group, Inc., CA | EHD |
| Jun 29, 2001 | K011619 | PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT Planmeca Oy | EHD |
| Nov 9, 2000 | K002062 | SAMSUNG 10DR IMPLANT SYSTEM Samsung Sds Co., Ltd. | EHD |
| Sep 1, 2000 | K002432 | STRATO X Villa Sistemi Medicali S.P.A. | EHD |
| Jul 13, 2000 | K001729 | FOCUS Instrumentarium Corp. | EHD |
| May 4, 2000 | K001248 | MULTI-PULSE 2000 Imaging Sciences Intl., Inc. | EHD |
| May 3, 2000 | K000771 | DIMAX 2 Planmeca Oy | EHD |
| May 2, 2000 | K000672 | HELIODENT VARIO Sirona Dental Systems GmbH | EHD |
| Apr 28, 2000 | K000428 | DIXI 2 Planmeca Oy, FI | EHD |
| Apr 18, 2000 | K000163 | PM 2002 PROLINE/AEC Planmeca Oy, FI | EHD |
| Apr 7, 2000 | K000061 | MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT Minxray, Inc. | EHD |
| Mar 16, 2000 | K000551 | IMAGE X-70 PLUS DENTAL X-RAY UNIT Medical Device Consultants, Inc. | EHD |
| Mar 14, 2000 | K994285 | ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH Dentsply Intl. | EHD |
| Sep 7, 1999 | K992610 | GENDEX 765DC, MODEL 110-0154 Dentsply Intl. | EHD |
| Jun 25, 1999 | K991455 | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, Trophy Radiologie, FR | EHD |
| Jun 22, 1999 | K991912 | MODIFICATION TO DIGIPAN Trophy Radiologie, FR | EHD |
| Jun 18, 1999 | K991518 | PANATOME Imaging Sciences Intl., Inc. | EHD |
| Jun 18, 1999 | K991310 | EXPLOR-X 70 Villa Sistemi Medicali S.P.A. | EHD |
| Feb 10, 1999 | K984030 | VIPERSOFT Integra Medical | EHD |
| Jan 14, 1999 | K984524 | AZTECH 70 Villa Sistemi Medicali S.P.A. | EHD |
| Apr 17, 1998 | K980581 | PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM Planmeca Oy, FI | EHD |
| Apr 14, 1998 | K980543 | DENOPTIX BARRIER ENVELOPE (SIZE 0-4) Dentsply Intl. | EHD |
| Mar 27, 1998 | K974877 | CRANEX TOME CEPH, OR CRANEX TOME Orion Corporation Soredex, FI | EHD |
| Jan 20, 1998 | K974077 | VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. J. Morita USA, Inc. | EHD |
| Jan 6, 1998 | K972921 | SANKO INTRAORAL DENTAL X-RAY Sanko X-Ray Manufacturing Co., Ltd. | EHD |
| Nov 21, 1997 | K973642 | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 Instrumentarium Imaging, Inc. | EHD |
| Nov 10, 1997 | K973476 | KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER Eastman Kodak Company | EHD |
| Oct 8, 1997 | K972968 | ROTOGRAPH PLUS Chicago X-Ray Systems, Inc. | EHD |
| Sep 15, 1997 | K972312 | SIEMENS ORTHOPHOS DS/DS CEPH Siemens AG | EHD |
| Sep 12, 1997 | K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD Pelton & Crane Co. | EHD |
| Sep 11, 1997 | K962422 | INFIMED DENTAL SYSTEM Infimed, Inc. | EHD |
| Sep 5, 1997 | K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM Pelton & Crane Co. | EHD |
| Aug 5, 1997 | K970812 | PM 2002 CC PROLINE Planmeca Oy, FI | EHD |
| May 14, 1997 | K970850 | SCANRITE DFS Scanrite Systems | EHD |
| Apr 1, 1997 | K970975 | PROSTYLE INTRA Planmeca Oy, FI | EHD |
| Mar 17, 1997 | K965203 | RADX SYSTEM Electro Medical Systems, Inc. | EHD |
| Feb 26, 1997 | K970263 | PM 2002 CC PROLINE Planmeca Oy, FI | EHD |
| Jan 27, 1997 | K965072 | PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT Kaycor Intl., Ltd. | EHD |
| Jan 2, 1997 | K963403 | ACURAY DIGITAL X-RAY New Image Industries, Inc. | EHD |
| Dec 23, 1996 | K964659 | ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM Dentsply Intl. | EHD |
| Dec 23, 1996 | K963699 | BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY Belmont Equipment Corp. | EHD |
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