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FDA 510(k)

SATURN 8000

K-Number: K120380 · 2012-03-09

ApplicantNew Medical Co., Ltd.
Decision Date2012-03-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SATURN 8000 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 2012-03-09 under 510(k) number K120380. 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?

SATURN 8000 is a medical device that received FDA 510(k) clearance on 2012-03-09. The listed applicant is New Medical Co., Ltd.. The 510(k) number is K120380.

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

SATURN 8000 received FDA 510(k) clearance on 2012-03-09, under 510(k) number K120380.

Who is the listed applicant for SATURN 8000?

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?

The FDA product code for SATURN 8000 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.

K110210SATURN 8000-GSK080589SATURN 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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