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General Purpose Fluoroscope Applications

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The provided text describes a 510(k) clearance letter from the FDA for a device called "Facts Monoblock Diagnostic X-Ray Tube Housing Assembly." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, etc.), or specific comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the given text. The document is solely a regulatory clearance letter acknowledging substantial equivalence based on prior submissions, not a scientific study report.

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The DynaRad NEO is a General Purpose Mobile X-Ray System that is specifically optimized to operate within the Neo Natal environment. The maximum output is 70 kVp at 50 mA from a 115/220 V outlet

NEO Mobile X-Ray System

The provided text describes a 510(k) premarket notification for the Dynarad Corporation's "NEO Mobile X-Ray System." It is a regulatory document from the FDA establishing substantial equivalence, not a study evaluating the device's performance against specific acceptance criteria.

Therefore, the input does not contain the information requested to fill out the table regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document indicates:

• Device Name: NEO Mobile X-Ray System
• Intended Use: General Purpose Mobile X-Ray System specifically optimized to operate within the Neo Natal environment.
• Regulatory Class: II

Without a performance study, it's impossible to provide the requested details.

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