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FDA 510(k)

INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL

K-Number: K001209 · 2000-06-01

ApplicantUsa Instruments, Inc.
Decision Date2000-06-01
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL is the device name listed in this FDA 510(k) record. The listed applicant is Usa Instruments, Inc.. It received FDA 510(k) clearance on 2000-06-01 under 510(k) number K001209. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL?

INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL is a medical device that received FDA 510(k) clearance on 2000-06-01. The listed applicant is Usa Instruments, Inc.. The 510(k) number is K001209.

When did INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL receive FDA 510(k) clearance?

INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL received FDA 510(k) clearance on 2000-06-01, under 510(k) number K001209.

Who is the listed applicant for INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL?

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

What is the FDA product code for INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL?

The FDA product code for INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL is MOS.

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Other records listing Usa Instruments, Inc. as applicant

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Related Devices (Code: MOS)

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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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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