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FDA 510(k)

DI-2000

K-Number: K943602 · 1995-05-12

ApplicantMiles Inc., Agfa Division
Decision Date1995-05-12
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DI-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Miles Inc., Agfa Division. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K943602. 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 DI-2000?

DI-2000 is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Miles Inc., Agfa Division. The 510(k) number is K943602.

When did DI-2000 receive FDA 510(k) clearance?

DI-2000 received FDA 510(k) clearance on 1995-05-12, under 510(k) number K943602.

Who is the listed applicant for DI-2000?

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

What is the FDA product code for DI-2000?

The FDA product code for DI-2000 is IYX.

Other records listing Miles Inc., Agfa Division 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.

K942883DIGITAL I.D. CAMERA

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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