M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
FDA 510(k) clearance K014191 · decided 2002-01-07
Clearance details
- K-number
- K014191
- Device name
- M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-12-21
- Decision date
- 2002-01-07
- Days to decision
- 17 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips OMNI II TEE Ultrasound Transducer recall (Z-1623-2026) | Philips Ultrasound, Inc | 2026-03-24 |
| 7.5MHZ Endo Transducer Probe recall (Z-2348-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| OMNI II TEE Transducer Probe recall (Z-2387-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| OMNI III TEE Transducer Probe recall (Z-2388-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Envisor, M2540 Diagnostic Ultrasound System recall (Z-0923-05) | Philips Ultrasound, Inc. | 2005-06-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |