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FDA 510(k)

GAMMA CAMERA

K-Number: K780969 · 1978-06-27

ApplicantMachlett Laboratories, Inc.
Decision Date1978-06-27
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Machlett Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-27 under 510(k) number K780969. 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 GAMMA CAMERA?

GAMMA CAMERA is a medical device that received FDA 510(k) clearance on 1978-06-27. The listed applicant is Machlett Laboratories, Inc.. The 510(k) number is K780969.

When did GAMMA CAMERA receive FDA 510(k) clearance?

GAMMA CAMERA received FDA 510(k) clearance on 1978-06-27, under 510(k) number K780969.

Who is the listed applicant for GAMMA CAMERA?

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

What is the FDA product code for GAMMA CAMERA?

The FDA product code for GAMMA CAMERA is IYX.

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Other records listing Machlett Laboratories, 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.

K813158RDP-2000K8102541.5` FOCAL SPOT RESOLUTION PATTERNK802888RAYTHEON MEDICAL IMAGING

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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