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FDA 510(k)

XIMATRON/CT OPTION

K-Number: K910647 · 1991-09-19

ApplicantFischer Imaging Corp.
Decision Date1991-09-19
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XIMATRON/CT OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Fischer Imaging Corp.. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K910647. 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 XIMATRON/CT OPTION?

XIMATRON/CT OPTION is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K910647.

When did XIMATRON/CT OPTION receive FDA 510(k) clearance?

XIMATRON/CT OPTION received FDA 510(k) clearance on 1991-09-19, under 510(k) number K910647.

Who is the listed applicant for XIMATRON/CT OPTION?

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

What is the FDA product code for XIMATRON/CT OPTION?

The FDA product code for XIMATRON/CT OPTION is KPQ.

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Other records listing Fischer Imaging Corp. 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.

K042095MAMMOTESTK021113MAMMOPATHK981414LC POSITIONERK973400MAMMOTEST ADAPTER DRIVERK964806MD-1835K961207EP-X BIPLANE

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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

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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