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FDA 510(k)

ADAC S315

K-Number: K921296 · 1992-05-28

ApplicantAdac Laboratories
Decision Date1992-05-28
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADAC S315 is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K921296. 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 ADAC S315?

ADAC S315 is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Adac Laboratories. The 510(k) number is K921296.

When did ADAC S315 receive FDA 510(k) clearance?

ADAC S315 received FDA 510(k) clearance on 1992-05-28, under 510(k) number K921296.

Who is the listed applicant for ADAC S315?

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

What is the FDA product code for ADAC S315?

The FDA product code for ADAC S315 is IYX.

Other records listing Adac Laboratories 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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