M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
FDA 510(k) clearance K001711 · decided 2000-06-20
Clearance details
- K-number
- K001711
- Device name
- M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
- Applicant
- Agilent Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-05
- Decision date
- 2000-06-20
- Days to decision
- 15 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
| Record | Firm | Date |
|---|---|---|
| MMR IHC Panel pharmDx (Dako Omnis) (P250004) | Agilent Technologies, Inc. | 2025-08-15 |
| PD-L1 IHC 22C3 pharmDx (Dako Omnis) (P150013/S028) | Agilent Technologies, Inc. | 2025-08-04 |
| PD-L1 IHC 28-8 pharmDx (P150025/S017) | Agilent Technologies, Inc. | 2025-06-27 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S002) | Agilent Technologies, Inc. | 2025-06-27 |
| 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 |