OS-2000 OPTICAL SONOGRAPHY SYSTEM
FDA 510(k) clearance K001510 · decided 2000-11-30
Clearance details
- K-number
- K001510
- Device name
- OS-2000 OPTICAL SONOGRAPHY SYSTEM
- Applicant
- Advanced Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-15
- Decision date
- 2000-11-30
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- NCS
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Richland, 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 |
|---|---|---|
| AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013886) | Advanced Diagnostics, Inc. | 2002-05-10 |
| ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013291) | Advanced Diagnostics, Inc. | 2001-11-14 |
Recalls involving this device
No recalls on record reference this clearance.