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FDA 510(k)

SPOT-FILM DEVICE 8835

K-Number: K842184 · 1984-07-17

ApplicantGeneral Electric Co.
Decision Date1984-07-17
Product CodeIXL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPOT-FILM DEVICE 8835 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1984-07-17 under 510(k) number K842184. 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 SPOT-FILM DEVICE 8835?

SPOT-FILM DEVICE 8835 is a medical device that received FDA 510(k) clearance on 1984-07-17. The listed applicant is General Electric Co.. The 510(k) number is K842184.

When did SPOT-FILM DEVICE 8835 receive FDA 510(k) clearance?

SPOT-FILM DEVICE 8835 received FDA 510(k) clearance on 1984-07-17, under 510(k) number K842184.

Who is the listed applicant for SPOT-FILM DEVICE 8835?

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

What is the FDA product code for SPOT-FILM DEVICE 8835?

The FDA product code for SPOT-FILM DEVICE 8835 is IXL.

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Other records listing General Electric Co. as applicant

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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, LLCK964806MD-1835Fischer Imaging Corp.K950317ADVANTX 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.

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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