FDA 510(k)

CT5137 HIGH RESOLUTION OPTION

K-Number: K780928 · 1978-06-14

Decision Date1978-06-14

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CT5137 HIGH RESOLUTION OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Emi Medical, Inc.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780928. 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 CT5137 HIGH RESOLUTION OPTION?

CT5137 HIGH RESOLUTION OPTION is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Emi Medical, Inc.. The 510(k) number is K780928.

When did CT5137 HIGH RESOLUTION OPTION receive FDA 510(k) clearance?

CT5137 HIGH RESOLUTION OPTION received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780928.

Who is the listed applicant for CT5137 HIGH RESOLUTION OPTION?

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

What is the FDA product code for CT5137 HIGH RESOLUTION OPTION?

The FDA product code for CT5137 HIGH RESOLUTION OPTION is JAK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Emi Medical, Inc. as applicant

K791429EMISONIC 4290 K781936SCANNER-EMI 7020 AND 7020R K781519EMI SIMULATOR REMOTE CONTROL CONSOLE K781051EMISONIC 4201 K780995COMPUTERIZED AXIAL TOMOGRAPHY K7809305543 INDEPENDENT VIEWING SYSTEM

View all 13 devices →

Related Devices (Code: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced 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.