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FDA 510(k)

FUSION FLAT PANEL

K-Number: K113449 · 2012-06-14

ApplicantIcrco, Inc.
Decision Date2012-06-14
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUSION FLAT PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Icrco, Inc.. It received FDA 510(k) clearance on 2012-06-14 under 510(k) number K113449. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSION FLAT PANEL?

FUSION FLAT PANEL is a medical device that received FDA 510(k) clearance on 2012-06-14. The listed applicant is Icrco, Inc.. The 510(k) number is K113449.

When did FUSION FLAT PANEL receive FDA 510(k) clearance?

FUSION FLAT PANEL received FDA 510(k) clearance on 2012-06-14, under 510(k) number K113449.

Who is the listed applicant for FUSION FLAT PANEL?

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

What is the FDA product code for FUSION FLAT PANEL?

The FDA product code for FUSION FLAT PANEL is MQB.

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 Icrco, 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.

K122510ICRCO 3600MK120753CLARISCTK082450IDR

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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