PHILIPS ESSENTA DR
FDA 510(k) clearance K070528 · decided 2007-03-09
Clearance details
- K-number
- K070528
- Device name
- PHILIPS ESSENTA DR
- Applicant
- Philips Medical Systems GmbH, Dmc
- Decision
- Substantially Equivalent
- Date received
- 2007-02-23
- Decision date
- 2007-03-09
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR i recall (Z-0584-2014) | Philips Medical Systems, Inc. | 2013-12-27 |
| Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta D recall (Z-2207-2012) | Philips Healthcare Inc. | 2012-08-15 |
| Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiograph recall (Z-0012-2011) | Philips Medical Systems North America Co. Phillips | 2010-10-06 |
| Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower) recall (Z-1895-2008) | Philips Medical Systems North America Co. Phillips | 2008-09-16 |