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FDA 510(k)

SYNGO INSPACE 4D

K-Number: K043469 · 2005-02-03

ApplicantSiemens AG Medical Solutions
Decision Date2005-02-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO INSPACE 4D is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG Medical Solutions. It received FDA 510(k) clearance on 2005-02-03 under 510(k) number K043469. 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 SYNGO INSPACE 4D?

SYNGO INSPACE 4D is a medical device that received FDA 510(k) clearance on 2005-02-03. The listed applicant is Siemens AG Medical Solutions. The 510(k) number is K043469.

When did SYNGO INSPACE 4D receive FDA 510(k) clearance?

SYNGO INSPACE 4D received FDA 510(k) clearance on 2005-02-03, under 510(k) number K043469.

Who is the listed applicant for SYNGO INSPACE 4D?

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

What is the FDA product code for SYNGO INSPACE 4D?

The FDA product code for SYNGO INSPACE 4D is JAK.

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Other records listing Siemens AG Medical Solutions as applicant

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.

K123920SYNGO.VIAK120331SYNGO CT DYNAMIC ANGIOK111079SYNGO.VIA WEB VIEWERK101666SYNGO. PLAZA VA20AK100637SYNGO.CT CORONARY ANALYSISK093612SYNGO.PLAZA

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Related Devices (Code: 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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