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FDA 510(k)

RADIOGRAPHIC FILM MARKING SYSTEM

K-Number: K913478 · 1991-10-15

ApplicantLorad Medical Systems, Inc.
Decision Date1991-10-15
Product CodeJAC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOGRAPHIC FILM MARKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K913478. The device is classified under product code JAC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOGRAPHIC FILM MARKING SYSTEM?

RADIOGRAPHIC FILM MARKING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Lorad Medical Systems, Inc.. The 510(k) number is K913478.

When did RADIOGRAPHIC FILM MARKING SYSTEM receive FDA 510(k) clearance?

RADIOGRAPHIC FILM MARKING SYSTEM received FDA 510(k) clearance on 1991-10-15, under 510(k) number K913478.

Who is the listed applicant for RADIOGRAPHIC FILM MARKING SYSTEM?

The FDA 510(k) record lists Lorad Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIOGRAPHIC FILM MARKING SYSTEM?

The FDA product code for RADIOGRAPHIC FILM MARKING SYSTEM is JAC.

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Other records listing Lorad Medical Systems, Inc. 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.

K921962LORAD DIGITAL SPOT MAMMOGRAPHYK922619DIGITIZER, MODEL # 3-000A-1518K913732MAMMOGRAPHIC X-RAY SYSTEMK894935S-70 PORTABLE DENTAL X-RAY SYSTEMK894643RT-125 ROUGH TERRAIN MOBILE X-RAY UNITK882875STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY

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Related Devices (Code: JAC)

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.

K942883DIGITAL I.D. CAMERAMiles Inc., Agfa DivisionK930752CT/MRI TOPOGRAPHIC MARKERI.Z.I. Corp.K932357FUJI EC ID CAMERAFujifilm Medical System U.S.A., Inc.K925892SOLSTICE XRAY RING MARKER PADSolstice Corp.K926404KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4LEastman Kodak CompanyK923533ADMARKPlanmeca USA, 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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