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FDA 510(k)

RTR-2000/RTR-4000

K-Number: K974307 · 1998-02-13

ApplicantTerarecon,Inc.
Decision Date1998-02-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RTR-2000/RTR-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K974307. 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 RTR-2000/RTR-4000?

RTR-2000/RTR-4000 is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Terarecon,Inc.. The 510(k) number is K974307.

When did RTR-2000/RTR-4000 receive FDA 510(k) clearance?

RTR-2000/RTR-4000 received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974307.

Who is the listed applicant for RTR-2000/RTR-4000?

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

What is the FDA product code for RTR-2000/RTR-4000?

The FDA product code for RTR-2000/RTR-4000 is JAK.

Other records listing Terarecon,Inc. 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.

K250288TeraRecon Cardiovascular.Calcification.CTK243158TeraRecon Aorta.CT (1.1.0)K241312TeraRecon Cardiac.Chambers.MR (1.0.0)K220349TeraRecon NeuroK200750Neuro.Al AlgorithmK191585iNtuition-Structural Heart Module

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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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