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FDA 510(k)

REAL TIME STEREOTIX

K-Number: K941191 · 1995-05-11

ApplicantGE Medical Systems
Decision Date1995-05-11
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REAL TIME STEREOTIX is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K941191. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL TIME STEREOTIX?

REAL TIME STEREOTIX is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is GE Medical Systems. The 510(k) number is K941191.

When did REAL TIME STEREOTIX receive FDA 510(k) clearance?

REAL TIME STEREOTIX received FDA 510(k) clearance on 1995-05-11, under 510(k) number K941191.

Who is the listed applicant for REAL TIME STEREOTIX?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAL TIME STEREOTIX?

The FDA product code for REAL TIME STEREOTIX is IZH.

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Other records listing GE Medical Systems 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.

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Related Devices (Code: IZH)

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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