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FDA 510(k)

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16

K-Number: K183548 · 2019-04-15

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-04-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-04-15 under approval number K183548. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16?

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 is a medical device that received FDA 510(k) clearance on 2019-04-15. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K183548.

When was SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 approved by the FDA?

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 received FDA 510(k) clearance on 2019-04-15, under approval number K183548.

What company makes SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16?

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16?

The FDA product code for SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 is JAK.

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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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