AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
FDA 510(k) clearance K013886 · decided 2002-05-10
Clearance details
- K-number
- K013886
- Device name
- AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
- Applicant
- Advanced Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-23
- Decision date
- 2002-05-10
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- NCS
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Preston, WA, 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 |
|---|---|---|
| ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013291) | Advanced Diagnostics, Inc. | 2001-11-14 |
| OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510) | Advanced Diagnostics, Inc. | 2000-11-30 |
Recalls involving this device
No recalls on record reference this clearance.