GE-700 INTRA ORAL X-RAY SYSTEM
FDA 510(k) clearance K781630 · decided 1978-12-04
Clearance details
- K-number
- K781630
- Device name
- GE-700 INTRA ORAL X-RAY SYSTEM
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-25
- Decision date
- 1978-12-04
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EAP
- Device class
- 2
- Regulation number
- 872.1810
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDICAL IMAGE PROCESSING UNIT (K113360) | Humanray Co,Ltd | 2012-02-07 |
| PROVU (TM) DENTAL X-RAY SYSTEM (K102573) | Advanced Image Science, Inc. | 2011-06-30 |
| MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K093453) | Schick Technologies, Inc. | 2009-11-30 |
| DENTRON SENSOR (K080738) | Dentron Systems, LLC | 2008-05-13 |
| THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (K052422) | Flow X-Ray Corp. | 2005-09-27 |
| MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K041385) | Schick Technologies, Inc. | 2004-06-07 |
| HELIODENT DS (K960819) | Pelton & Crane Co. | 1996-03-29 |
| ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (K960028) | Dentsply Intl. | 1996-03-01 |
| ATLANTIS (K953936) | Trophy Radiologie | 1995-12-28 |
| EXPLOR-X (AZTEH) HF (K954565) | Chicago X-Ray Systems, Inc. | 1995-10-27 |
| LUMIX 70B (K951734) | Emix U.S.A., Inc. | 1995-07-20 |
| TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (K950533) | Trophy Radiologie | 1995-06-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |