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FDA 510(k)

BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY

K-Number: K991336 · 1999-07-12

Decision Date1999-07-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). It received FDA 510(k) clearance on 1999-07-12 under 510(k) number K991336. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY?

BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY is a medical device that received FDA 510(k) clearance on 1999-07-12. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). The 510(k) number is K991336.

When did BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY receive FDA 510(k) clearance?

BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY received FDA 510(k) clearance on 1999-07-12, under 510(k) number K991336.

Who is the listed applicant for BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY?

The FDA 510(k) record lists Medical Instrumentation & Diagnostics Corp.(Midco) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY?

The FDA product code for BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY is IYE.

Related Clinical Trials

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.

Other records listing Medical Instrumentation & Diagnostics Corp.(Midco) 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.

Related Devices (Code: IYE)

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.

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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