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FDA 510(k)

LUMAGEM SCINTILLATION CAMERA

K-Number: K993813 · 2000-01-18

ApplicantGamma Medica
Decision Date2000-01-18
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUMAGEM SCINTILLATION CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Medica. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K993813. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMAGEM SCINTILLATION CAMERA?

LUMAGEM SCINTILLATION CAMERA is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Gamma Medica. The 510(k) number is K993813.

When did LUMAGEM SCINTILLATION CAMERA receive FDA 510(k) clearance?

LUMAGEM SCINTILLATION CAMERA received FDA 510(k) clearance on 2000-01-18, under 510(k) number K993813.

Who is the listed applicant for LUMAGEM SCINTILLATION CAMERA?

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

What is the FDA product code for LUMAGEM SCINTILLATION CAMERA?

The FDA product code for LUMAGEM SCINTILLATION CAMERA is IYX.

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Related Devices (Code: IYX)

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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