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FDA 510(k)

HRSW OPTION FOR CT TWIN FLASH

K-Number: K945512 · 1995-03-14

ApplicantElscint, Inc.
Decision Date1995-03-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HRSW OPTION FOR CT TWIN FLASH is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1995-03-14 under 510(k) number K945512. 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 HRSW OPTION FOR CT TWIN FLASH?

HRSW OPTION FOR CT TWIN FLASH is a medical device that received FDA 510(k) clearance on 1995-03-14. The listed applicant is Elscint, Inc.. The 510(k) number is K945512.

When did HRSW OPTION FOR CT TWIN FLASH receive FDA 510(k) clearance?

HRSW OPTION FOR CT TWIN FLASH received FDA 510(k) clearance on 1995-03-14, under 510(k) number K945512.

Who is the listed applicant for HRSW OPTION FOR CT TWIN FLASH?

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

What is the FDA product code for HRSW OPTION FOR CT TWIN FLASH?

The FDA product code for HRSW OPTION FOR CT TWIN FLASH is JAK.

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Other records listing Elscint, 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.

K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK982060VOLUMAX CT IMAGING SYSTEMK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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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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