# K014191: M2540 Diagnostic Ultrasound System, Model M2540

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jan 7, 2002 after 17 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
70 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) M2410 Ultrasound system with transducers: named in the summary without a submission number
- (no number) Philips sector, linear and endo-cavity ultrasound transducers: named in the summary without a submission number

## Most influential descendants
- K040596: Ultrasound Imaging System, Model 7300 (2004), 67 descendants of its own
- K050326: 7350 Ultrasound Imaging System, Model 7350 (2005), 66 descendants of its own
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100 (2005), 64 descendants of its own
- K051308: Mylab 70 Ultrasound Imaging System (2005), 64 descendants of its own
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 (2006), 62 descendants of its own

## Recalls of this device
- Sep 5, 2025 · Class III · Z-1623-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2348-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2387-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2388-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 13, 2005 · Not classified · Z-0923-05: A defect in the software allows incorrect measurement results to be entered into the system's built-in report.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K014191
Methodology: https://510kreport.com/methodology