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FDA 510(k)

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]

K-Number: K961844 · 1996-10-23

ApplicantRadionics Software Applications, Inc.
Decision Date1996-10-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] 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 1996-10-23 under 510(k) number K961844. 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 OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]?

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] is a medical device that received FDA 510(k) clearance on 1996-10-23. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K961844.

When did OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] receive FDA 510(k) clearance?

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] received FDA 510(k) clearance on 1996-10-23, under 510(k) number K961844.

Who is the listed applicant for OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]?

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 OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]?

The FDA product code for OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] 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.

K990326OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMIIK974602OPTICAL TRACKING SYSTEM (OTS)K972905XPLAN-1K964801OPTICAL TRACKING SYSTEM (OTS)K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYK960071IMAGEFUSION

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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

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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