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FDA 510(k)

IMAGE MEDICAL ACQUISITION STATION (IMAS)

K-Number: K042700 · 2004-11-08

ApplicantErad Imagemedical Corp.
Decision Date2004-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE MEDICAL ACQUISITION STATION (IMAS) is the device name listed in this FDA 510(k) record. The listed applicant is Erad Imagemedical Corp.. It received FDA 510(k) clearance on 2004-11-08 under 510(k) number K042700. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE MEDICAL ACQUISITION STATION (IMAS)?

IMAGE MEDICAL ACQUISITION STATION (IMAS) is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Erad Imagemedical Corp.. The 510(k) number is K042700.

When did IMAGE MEDICAL ACQUISITION STATION (IMAS) receive FDA 510(k) clearance?

IMAGE MEDICAL ACQUISITION STATION (IMAS) received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042700.

Who is the listed applicant for IMAGE MEDICAL ACQUISITION STATION (IMAS)?

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

What is the FDA product code for IMAGE MEDICAL ACQUISITION STATION (IMAS)?

The FDA product code for IMAGE MEDICAL ACQUISITION STATION (IMAS) is LLZ.

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Other records listing Erad Imagemedical 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.

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Related Devices (Code: LLZ)

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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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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