MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
FDA 510(k) clearance K031552 · decided 2003-05-30
Clearance details
- K-number
- K031552
- Device name
- MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
- Applicant
- Medison America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-19
- Decision date
- 2003-05-30
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cypress, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Di recall (Z-0522-2009) | Philips Medical Systems | 2008-12-31 |
| Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound Sy recall (Z-0523-2009) | Philips Medical Systems | 2008-12-31 |
| Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for di recall (Z-2013-2008) | Philips Medical Systems | 2008-09-16 |
| Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for di recall (Z-2014-2008) | Philips Medical Systems | 2008-09-16 |
| Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for di recall (Z-2015-2008) | Philips Medical Systems | 2008-09-16 |