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FDA 510(k)

HIPAX MEDICAL IMAGING SOFTWARE

K-Number: K052411 · 2005-09-21

ApplicantSteinhart Medizinsysteme GmbH
Decision Date2005-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIPAX MEDICAL IMAGING SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Steinhart Medizinsysteme GmbH. It received FDA 510(k) clearance on 2005-09-21 under 510(k) number K052411. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIPAX MEDICAL IMAGING SOFTWARE?

HIPAX MEDICAL IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Steinhart Medizinsysteme GmbH. The 510(k) number is K052411.

When did HIPAX MEDICAL IMAGING SOFTWARE receive FDA 510(k) clearance?

HIPAX MEDICAL IMAGING SOFTWARE received FDA 510(k) clearance on 2005-09-21, under 510(k) number K052411.

Who is the listed applicant for HIPAX MEDICAL IMAGING SOFTWARE?

The FDA 510(k) record lists Steinhart Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIPAX MEDICAL IMAGING SOFTWARE?

The FDA product code for HIPAX MEDICAL IMAGING SOFTWARE is LLZ.

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Related Devices (Code: LLZ)

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

View on FDA Database →

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

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