ULTRASOUND IMAGING SYSTEM, MODEL 7300
FDA 510(k) clearance K040596 · decided 2004-03-31
Clearance details
- K-number
- K040596
- Device name
- ULTRASOUND IMAGING SYSTEM, MODEL 7300
- Applicant
- Esaote, S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-08
- Decision date
- 2004-03-31
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Indianpolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardio recall (Z-2167-2014) | Biosound Esaote, Inc. | 2014-08-08 |
| MyLab30CV Ultrasound Imaging System; model 9807300000. recall (Z-1401-05) | Biosound Esaote, Inc. | 2005-08-25 |
| MyLab30CV Ultrasound Imaging System; model 9807300001. recall (Z-1402-05) | Biosound Esaote, Inc. | 2005-08-25 |
| MyLab25 Ultrasound Imaging System; Model 9807300002. recall (Z-1403-05) | Biosound Esaote, Inc. | 2005-08-25 |