FDA 510(k)

ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8

K-Number: K090178 · 2009-04-24

ApplicantNeusoft Positron Medical Systems Co., Ltd.

Decision Date2009-04-24

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 is the device name listed in this FDA 510(k) record. The listed applicant is Neusoft Positron Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2009-04-24 under 510(k) number K090178. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8?

ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 is a medical device that received FDA 510(k) clearance on 2009-04-24. The listed applicant is Neusoft Positron Medical Systems Co., Ltd.. The 510(k) number is K090178.

When did ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 receive FDA 510(k) clearance?

ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 received FDA 510(k) clearance on 2009-04-24, under 510(k) number K090178.

Who is the listed applicant for ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8?

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

What is the FDA product code for ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8?

The FDA product code for ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 is KPS.

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Official Source

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