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FDA 510(k)

MD-1835

K-Number: K964806 · 1997-03-04

ApplicantFischer Imaging Corp.
Decision Date1997-03-04
Product CodeIXL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MD-1835 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 1997-03-04 under 510(k) number K964806. The device is classified under product code IXL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MD-1835?

MD-1835 is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K964806.

When did MD-1835 receive FDA 510(k) clearance?

MD-1835 received FDA 510(k) clearance on 1997-03-04, under 510(k) number K964806.

Who is the listed applicant for MD-1835?

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 MD-1835?

The FDA product code for MD-1835 is IXL.

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 DRIVERK961207EP-X BIPLANEK961022TANGENT VI TABLE

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Related Devices (Code: IXL)

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.

K111304OPTIMA XR120Ge Medical Systems, LLCK950317ADVANTX 1824 SPOTFILM DEVICEGE Medical SystemsK940386KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LPEastman Kodak CompanyK942367AXT 1400 SPOTFILM DEVICEApplied X-Ray Technologies, Inc.K924593DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4Philips Medical Systems, Inc.K902403ELITE R/F SPOT FILM DRIVERms Div.

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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