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The DP-50 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(pediatric) and peripheral vascular exams.

The DP-50 Digital Ultrasonic Diagnostic Imaging System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, or their combined mode B+M Mode. This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-50 Digital Ultrasonic Diagnostic Imaging System. It focuses on demonstrating substantial equivalence to predicate devices, and includes:

• Device name and classification.
• Intended use: A list of clinical applications for which the ultrasound system is intended for use (e.g., fetal, abdominal, pediatric, etc.) and specifies the applicable patient populations (adults, pregnant women, pediatric patients, neonates).
• Comparison with predicate devices: Mentions that it is comparable to and substantially equivalent to other Mindray systems (Mindray DP-6900, M5, M7) based on technological characteristics, safety, effectiveness, and intended uses.
• Non-clinical tests: States that the device has been evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards (UD 2, UD 3, IEC 60601-1, etc.).
• Conclusion of substantial equivalence: Based on the above points, the FDA determined the device to be substantially equivalent to legally marketed predicate devices.
• Indication for Use forms for various transducers: These forms list the clinical applications and modes of operation (B-mode, M-mode, Combined B+M) for each specific transducer model (35C50EA, 65C15EA, 65EC10EA, 75L38EA, 75L53EA, 10L24EA, 65EB10EA). These tables indicate whether an indication is "new" (N) for this device or "previously cleared" (P) for similar predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text. The document is a regulatory submission for premarket notification (510(k)), which typically focuses on demonstrating equivalence to existing devices rather than detailing novel performance studies with specific acceptance criteria.

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