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FDA 510(k)

APEX 215M MOBILE ANGER CAMERA

K-Number: K884673 · 1989-04-14

ApplicantElscint, Inc.
Decision Date1989-04-14
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APEX 215M MOBILE ANGER CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K884673. 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 APEX 215M MOBILE ANGER CAMERA?

APEX 215M MOBILE ANGER CAMERA is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Elscint, Inc.. The 510(k) number is K884673.

When did APEX 215M MOBILE ANGER CAMERA receive FDA 510(k) clearance?

APEX 215M MOBILE ANGER CAMERA received FDA 510(k) clearance on 1989-04-14, under 510(k) number K884673.

Who is the listed applicant for APEX 215M MOBILE ANGER CAMERA?

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

What is the FDA product code for APEX 215M MOBILE ANGER CAMERA?

The FDA product code for APEX 215M MOBILE ANGER CAMERA is IYX.

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Other records listing Elscint, Inc. as applicant

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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.

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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