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FDA 510(k)

MULTICARE PLATINUM SYSTEM AND ACCESSORIES

K-Number: K030666 · 2003-03-25

ApplicantLorad, A Hologic Co.
Decision Date2003-03-25
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTICARE PLATINUM SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lorad, A Hologic Co.. It received FDA 510(k) clearance on 2003-03-25 under 510(k) number K030666. 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 MULTICARE PLATINUM SYSTEM AND ACCESSORIES?

MULTICARE PLATINUM SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2003-03-25. The listed applicant is Lorad, A Hologic Co.. The 510(k) number is K030666.

When did MULTICARE PLATINUM SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

MULTICARE PLATINUM SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2003-03-25, under 510(k) number K030666.

Who is the listed applicant for MULTICARE PLATINUM SYSTEM AND ACCESSORIES?

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

What is the FDA product code for MULTICARE PLATINUM SYSTEM AND ACCESSORIES?

The FDA product code for MULTICARE PLATINUM SYSTEM AND ACCESSORIES is IZH.

Related Clinical Trials

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.

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Other records listing Lorad, A Hologic Co. 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.

K122836AFFIRM BREAST BIOPSY GUIDANCE SYSTEMK071542DIGITAL STEREOLOC IIK013290MODIFIED 650 MAMMOGRAPHY SYSTEMK011987MODIFIED M-IV MAMMOGRAPHY SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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