M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
FDA 510(k) clearance K002470 · decided 2000-09-08
Clearance details
- K-number
- K002470
- Device name
- M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
- Applicant
- Agilent Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-11
- Decision date
- 2000-09-08
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Andover, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| PD-L1 IHC 22C3 PHARMDX (P150013/S030) | Agilent Technologies, Inc. | 2025-06-27 |
| Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S002) | Agilent Technologies, Inc. | 2025-02-28 |
| PD-L1 IHC 22C3 pharmDx (P150013/S029) | Agilent Technologies, Inc. | 2025-02-28 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S001) | Agilent Technologies, Inc. | 2025-02-28 |