LUMIX 70B
FDA 510(k) clearance K951734 · decided 1995-07-20
Clearance details
- K-number
- K951734
- Device name
- LUMIX 70B
- Applicant
- Emix U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-14
- Decision date
- 1995-07-20
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- EAP
- Device class
- 2
- Regulation number
- 872.1810
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- King Of Prussia, PA, 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 |
| TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (K950533) | Trophy Radiologie | 1995-06-30 |
| TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY (K950532) | Trophy Radiologie | 1995-04-19 |
Recalls involving this device
No recalls on record reference this clearance.