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FDA 510(k)

THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL

K-Number: K895442 · 1989-12-14

ApplicantAltek Corp.
Decision Date1989-12-14
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL is the device name listed in this FDA 510(k) record. The listed applicant is Altek Corp.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K895442. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL?

THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Altek Corp.. The 510(k) number is K895442.

When did THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL receive FDA 510(k) clearance?

THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL received FDA 510(k) clearance on 1989-12-14, under 510(k) number K895442.

Who is the listed applicant for THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL?

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

What is the FDA product code for THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL?

The FDA product code for THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL is KPQ.

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Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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