ACHILLES INSIGHT ULTRASONOMETER
FDA premarket approval P970040/S002 · decided 2001-10-24
Approval details
- PMA number
- P970040
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACHILLES INSIGHT ULTRASONOMETER
- Generic name
- Bone sonometer
- Applicant
- Ge Lunar Corp.
- Date received
- 2001-05-07
- Decision date
- 2001-10-24
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Madison, WI
- Statement
- APPROVAL FOR: 1) THE ADDITION OF 2-D REAL TIME PREVIEW IMAGING; 2) A NEW RECEIVER TRANSDUCER ARRAY; 3) HIGHER CONTRAST COLOR LCD GRAPHICS AND IMAGING; AND 4) AN OPTIONAL LARGER SCREEN DISPLAY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DPX SERIES BRAVO DUO BONE DENSITOMETER (K030962) | Ge Lunar Corp. | 2003-07-25 |
| DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE (K023554) | Ge Lunar Corp. | 2002-12-20 |
| ADVANCED HIP ASSESSMENT SOFTWARE (K011917) | Ge Lunar Corp. | 2001-08-03 |