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FDA 510(k)

SATURN 8000-GS

K-Number: K110210 · 2011-04-20

ApplicantNew Medical Co., Ltd.
Decision Date2011-04-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SATURN 8000-GS is the device name listed in this FDA 510(k) record. The listed applicant is New Medical Co., Ltd.. It received FDA 510(k) clearance on 2011-04-20 under 510(k) number K110210. 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 SATURN 8000-GS?

SATURN 8000-GS is a medical device that received FDA 510(k) clearance on 2011-04-20. The listed applicant is New Medical Co., Ltd.. The 510(k) number is K110210.

When did SATURN 8000-GS receive FDA 510(k) clearance?

SATURN 8000-GS received FDA 510(k) clearance on 2011-04-20, under 510(k) number K110210.

Who is the listed applicant for SATURN 8000-GS?

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

What is the FDA product code for SATURN 8000-GS?

The FDA product code for SATURN 8000-GS 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 New Medical 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.

K120380SATURN 8000K080589SATURN 9000-810K072984SATURN 9000-550K072983SATURN 9000-750K063710SATURN 9000

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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