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FDA 510(k)

LINUS

K-Number: K812398 · 1981-11-10

ApplicantFischer Imaging Corp.
Decision Date1981-11-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINUS 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 1981-11-10 under 510(k) number K812398. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINUS?

LINUS is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K812398.

When did LINUS receive FDA 510(k) clearance?

LINUS received FDA 510(k) clearance on 1981-11-10, under 510(k) number K812398.

Who is the listed applicant for LINUS?

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 LINUS?

The FDA product code for LINUS is IYO.

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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: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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