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FDA 510(k)

INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

K-Number: K071513 · 2007-06-26

ApplicantSiemens Medical Solutions
Decision Date2007-06-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions. It received FDA 510(k) clearance on 2007-06-26 under 510(k) number K071513. 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 INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is a medical device that received FDA 510(k) clearance on 2007-06-26. The listed applicant is Siemens Medical Solutions. The 510(k) number is K071513.

When did INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY receive FDA 510(k) clearance?

INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY received FDA 510(k) clearance on 2007-06-26, under 510(k) number K071513.

Who is the listed applicant for INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

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

What is the FDA product code for INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY?

The FDA product code for INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY is JAK.

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Other records listing Siemens 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.

K250738YSIO X.preeK250660LUMINOS Q.namix T; LUMINOS Q.namix RK233543YSIO X.preeK233532MULTIX Impact EK231577MOBILETT ImpactK221281Multitom Rax

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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