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FDA 510(k)

LORAD M-IIE MODIFICATION

K-Number: K934748 · 1994-01-31

ApplicantLorad Corp.
Decision Date1994-01-31
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LORAD M-IIE MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Corp.. It received FDA 510(k) clearance on 1994-01-31 under 510(k) number K934748. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORAD M-IIE MODIFICATION?

LORAD M-IIE MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Lorad Corp.. The 510(k) number is K934748.

When did LORAD M-IIE MODIFICATION receive FDA 510(k) clearance?

LORAD M-IIE MODIFICATION received FDA 510(k) clearance on 1994-01-31, under 510(k) number K934748.

Who is the listed applicant for LORAD M-IIE MODIFICATION?

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

What is the FDA product code for LORAD M-IIE MODIFICATION?

The FDA product code for LORAD M-IIE MODIFICATION is IZH.

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Other records listing Lorad 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.

K992280LORAD 1-650 (INTERNATIONAL 650)K974460LITE TOUCH ERBIUM LASER TREATMENT SYSTEMK973631LORAD M-III ELITE (M-III E)K952210LORAD STEROLOC IIK945241LORAD M-IV, LORAD M-IVIK950608DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION

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Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, 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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