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FDA 510(k)

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII

K-Number: K990326 · 1999-03-04

ApplicantRadionics Software Applications, Inc.
Decision Date1999-03-04
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1999-03-04 under 510(k) number K990326. 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 OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII?

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII is a medical device that received FDA 510(k) clearance on 1999-03-04. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K990326.

When did OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII receive FDA 510(k) clearance?

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII received FDA 510(k) clearance on 1999-03-04, under 510(k) number K990326.

Who is the listed applicant for OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII?

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

What is the FDA product code for OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII?

The FDA product code for OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII is HAW.

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Other records listing Radionics Software Applications, 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.

K974602OPTICAL TRACKING SYSTEM (OTS)K972905XPLAN-1K964801OPTICAL TRACKING SYSTEM (OTS)K961844OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYK960071IMAGEFUSION

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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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