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FDA 510(k)

ACE COMPUTER SYSTEM

K-Number: K853482 · 1986-01-01

ApplicantCardiac Medical Systems Corp.
Decision Date1986-01-01
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACE COMPUTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Medical Systems Corp.. It received FDA 510(k) clearance on 1986-01-01 under 510(k) number K853482. 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 ACE COMPUTER SYSTEM?

ACE COMPUTER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-01-01. The listed applicant is Cardiac Medical Systems Corp.. The 510(k) number is K853482.

When did ACE COMPUTER SYSTEM receive FDA 510(k) clearance?

ACE COMPUTER SYSTEM received FDA 510(k) clearance on 1986-01-01, under 510(k) number K853482.

Who is the listed applicant for ACE COMPUTER SYSTEM?

The FDA 510(k) record lists Cardiac Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE COMPUTER SYSTEM?

The FDA product code for ACE COMPUTER SYSTEM 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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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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