510(k) K781287
- Device
- DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH
- Applicant
- SIEMENS CORP.
- 510(k) number
- K781287
- Product code
- EAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-09-11
- Date received
- 1978-07-26
- Regulation
- 872.1830
- Classification name
- Cephalometer
- Medical specialty
- Dental
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2520313
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030699 | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC | J. Morita Mfg. Corp. | 2003-05-29 |
| K021372 | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY | J. Morita USA, Inc. | 2002-06-07 |
| K944162 | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | Teledyne Water Pik | 1994-11-29 |
| K920189 | GX-C CEPHALOMETER | Gendex Corp. | 1992-04-28 |
| K896099 | DIGIGRAPH DIAGNOSTIC WORK/STATION | Dolphin Imaging Systems | 1991-01-31 |
| K870243 | BURNETT TMJ APPLIANCE | Medrad, Inc. | 1987-02-24 |
| K842463 | GX CEPH | Gendex Corp. | 1984-08-02 |
| K833006 | CEPHALOMETER & FIXATOR | Modern Systems, Inc. | 1984-01-03 |
| K810538 | PLASTICEPH | Morningstar Dental Co. | 1981-04-29 |
Legacy Summary#
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FDA Review#
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