ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
FDA 510(k) clearance K013291 · decided 2001-11-14
Clearance details
- K-number
- K013291
- Device name
- ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
- Applicant
- Advanced Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-02
- Decision date
- 2001-11-14
- Days to decision
- 43 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
+ Add to Predicate Builder ◉ Watch Advanced Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013886) | Advanced Diagnostics, Inc. | 2002-05-10 |
| OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510) | Advanced Diagnostics, Inc. | 2000-11-30 |
Recalls involving this device
No recalls on record reference this clearance.