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FDA 510(k)

SONOLINE LX

K-Number: K853946 · 1986-01-16

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1986-01-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOLINE LX is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K853946. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOLINE LX?

SONOLINE LX is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K853946.

When did SONOLINE LX receive FDA 510(k) clearance?

SONOLINE LX received FDA 510(k) clearance on 1986-01-16, under 510(k) number K853946.

Who is the listed applicant for SONOLINE LX?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOLINE LX?

The FDA product code for SONOLINE LX is IYO.

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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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