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This device is intended to be used in the fluoroscopy and fluorography.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this notification, the intended use of the IA-16LM is the same as that of predicate device IA-16VMA12 in KV-RF (K984111).
The purposes of the IA-16LM are also the same as that of the IA-16VMA12 in KV-RF (K984111) and there are no additional indications.

Shimadzu Image Amplifiers: IA-16LM IA-16LT, IA-16LD, IA-12LD/HG, IA-12LT/F

I am sorry, but the provided text from the FDA 510(k) summary for the Shimadzu Image Amplifiers does not contain sufficient information to answer your request regarding acceptance criteria and study details.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample size for test sets or data provenance.
3. Information on the number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document mainly focuses on the regulatory clearance based on substantial equivalence and refers to the "Indications For Use" statement. To find the information you're looking for, you would typically need to review the full 510(k) submission, specifically the sections related to performance data and clinical studies, which are not included in these provided pages.

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