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FDA 510(k)

SYSTEM SEVENTY SEVEN

K-Number: K885054 · 1989-04-19

ApplicantScinticor, Inc.
Decision Date1989-04-19
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYSTEM SEVENTY SEVEN is the device name listed in this FDA 510(k) record. The listed applicant is Scinticor, Inc.. It received FDA 510(k) clearance on 1989-04-19 under 510(k) number K885054. 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 SYSTEM SEVENTY SEVEN?

SYSTEM SEVENTY SEVEN is a medical device that received FDA 510(k) clearance on 1989-04-19. The listed applicant is Scinticor, Inc.. The 510(k) number is K885054.

When did SYSTEM SEVENTY SEVEN receive FDA 510(k) clearance?

SYSTEM SEVENTY SEVEN received FDA 510(k) clearance on 1989-04-19, under 510(k) number K885054.

Who is the listed applicant for SYSTEM SEVENTY SEVEN?

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

What is the FDA product code for SYSTEM SEVENTY SEVEN?

The FDA product code for SYSTEM SEVENTY SEVEN is IYX.

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.

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Other records listing Scinticor, 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.

K931193SIM-400 SYSTEM

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

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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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