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FDA 510(k)

HYPERPACS PACS AND TELERAFIOLOGY SYSTEM

K-Number: K950343 · 1995-04-12

ApplicantRogan Imaging Corp.
Decision Date1995-04-12
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HYPERPACS PACS AND TELERAFIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rogan Imaging Corp.. It received FDA 510(k) clearance on 1995-04-12 under 510(k) number K950343. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERPACS PACS AND TELERAFIOLOGY SYSTEM?

HYPERPACS PACS AND TELERAFIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-12. The listed applicant is Rogan Imaging Corp.. The 510(k) number is K950343.

When did HYPERPACS PACS AND TELERAFIOLOGY SYSTEM receive FDA 510(k) clearance?

HYPERPACS PACS AND TELERAFIOLOGY SYSTEM received FDA 510(k) clearance on 1995-04-12, under 510(k) number K950343.

Who is the listed applicant for HYPERPACS PACS AND TELERAFIOLOGY SYSTEM?

The FDA 510(k) record lists Rogan Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERPACS PACS AND TELERAFIOLOGY SYSTEM?

The FDA product code for HYPERPACS PACS AND TELERAFIOLOGY SYSTEM is LMD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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