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FDA 510(k)

IMAGER

K-Number: K883831 · 1988-11-21

ApplicantFischer Imaging Corp.
Decision Date1988-11-21
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGER 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 1988-11-21 under 510(k) number K883831. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGER?

IMAGER is a medical device that received FDA 510(k) clearance on 1988-11-21. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K883831.

When did IMAGER receive FDA 510(k) clearance?

IMAGER received FDA 510(k) clearance on 1988-11-21, under 510(k) number K883831.

Who is the listed applicant for IMAGER?

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 IMAGER?

The FDA product code for IMAGER is IZI.

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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: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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