FDA 510(k)

SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING

K-Number: K980557 · 1998-04-24

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date1998-04-24

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING 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 1998-04-24 under 510(k) number K980557. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING?

SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K980557.

When did SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING receive FDA 510(k) clearance?

SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING received FDA 510(k) clearance on 1998-04-24, under 510(k) number K980557.

Who is the listed applicant for SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING?

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 ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING?

The FDA product code for SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING is IYN.

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Official Source

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