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FDA 510(k)

LIGHTSPEED 2.0CT SCANNER SYSTEM

K-Number: K000300 · 2000-02-15

ApplicantGe Medical Systems, Inc.
Decision Date2000-02-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIGHTSPEED 2.0CT SCANNER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-02-15 under 510(k) number K000300. 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 LIGHTSPEED 2.0CT SCANNER SYSTEM?

LIGHTSPEED 2.0CT SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-15. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K000300.

When did LIGHTSPEED 2.0CT SCANNER SYSTEM receive FDA 510(k) clearance?

LIGHTSPEED 2.0CT SCANNER SYSTEM received FDA 510(k) clearance on 2000-02-15, under 510(k) number K000300.

Who is the listed applicant for LIGHTSPEED 2.0CT SCANNER SYSTEM?

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

What is the FDA product code for LIGHTSPEED 2.0CT SCANNER SYSTEM?

The FDA product code for LIGHTSPEED 2.0CT SCANNER SYSTEM is JAK.

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Other records listing Ge Medical Systems, 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.

K091673GE LIGHTSPEED ACT FP16K082104GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEMK042844GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COILK042053INNOVA 4100, INNOVA 3100K040125SENOGRAPHIC STEREOK033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

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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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