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FDA 510(k)

LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM

K-Number: K950431 · 1995-05-04

ApplicantOpen Mri, Inc.
Decision Date1995-05-04
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Open Mri, Inc.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K950431. 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 LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM?

LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is Open Mri, Inc.. The 510(k) number is K950431.

When did LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM receive FDA 510(k) clearance?

LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM received FDA 510(k) clearance on 1995-05-04, under 510(k) number K950431.

Who is the listed applicant for LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM?

The FDA 510(k) record lists Open Mri, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM?

The FDA product code for LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM is LMD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Open Mri, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922470IES, IMAGE ENHANCEMENT SYSTEM

Related Devices (Code: LMD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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