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FDA 510(k)

STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE

K-Number: K901883 · 1991-03-07

ApplicantStereotactic Image Systems, Inc.
Decision Date1991-03-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Stereotactic Image Systems, Inc.. It received FDA 510(k) clearance on 1991-03-07 under 510(k) number K901883. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE?

STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE is a medical device that received FDA 510(k) clearance on 1991-03-07. The listed applicant is Stereotactic Image Systems, Inc.. The 510(k) number is K901883.

When did STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE receive FDA 510(k) clearance?

STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE received FDA 510(k) clearance on 1991-03-07, under 510(k) number K901883.

Who is the listed applicant for STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE?

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

What is the FDA product code for STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE?

The FDA product code for STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE is HAW.

Related Clinical Trials

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Related Devices (Code: HAW)

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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