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FDA 510(k)

APEX 115 NUCLEAR MEDICINE PROCESSOR

K-Number: K884672 · 1989-04-17

ApplicantElscint, Inc.
Decision Date1989-04-17
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APEX 115 NUCLEAR MEDICINE PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K884672. 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 115 NUCLEAR MEDICINE PROCESSOR?

APEX 115 NUCLEAR MEDICINE PROCESSOR is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Elscint, Inc.. The 510(k) number is K884672.

When did APEX 115 NUCLEAR MEDICINE PROCESSOR receive FDA 510(k) clearance?

APEX 115 NUCLEAR MEDICINE PROCESSOR received FDA 510(k) clearance on 1989-04-17, under 510(k) number K884672.

Who is the listed applicant for APEX 115 NUCLEAR MEDICINE PROCESSOR?

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 115 NUCLEAR MEDICINE PROCESSOR?

The FDA product code for APEX 115 NUCLEAR MEDICINE PROCESSOR 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.

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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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