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FDA 510(k)

DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP

K-Number: K102321 · 2011-02-11

ApplicantSamsung Mobile Display Co., Ltd.
Decision Date2011-02-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Mobile Display Co., Ltd.. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K102321. 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 DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP?

DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Samsung Mobile Display Co., Ltd.. The 510(k) number is K102321.

When did DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP receive FDA 510(k) clearance?

DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP received FDA 510(k) clearance on 2011-02-11, under 510(k) number K102321.

Who is the listed applicant for DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP?

The FDA 510(k) record lists Samsung Mobile Display Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP?

The FDA product code for DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP 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 Samsung Mobile Display Co., Ltd. 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.

K112751SDX-4343CSK112558DIGITAL FLAT PANEL X-RAY DETECTORK102587LLX240AB01K090742DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A

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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