FDA 510(k)

G.E. SCAN CAPABILITY CAT.#B7815F

K-Number: K802045 · 1980-10-23

Decision Date1980-10-23

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

G.E. SCAN CAPABILITY CAT.#B7815F is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802045. 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 G.E. SCAN CAPABILITY CAT.#B7815F?

G.E. SCAN CAPABILITY CAT.#B7815F is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is General Electric Co.. The 510(k) number is K802045.

When did G.E. SCAN CAPABILITY CAT.#B7815F receive FDA 510(k) clearance?

G.E. SCAN CAPABILITY CAT.#B7815F received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802045.

Who is the listed applicant for G.E. SCAN CAPABILITY CAT.#B7815F?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G.E. SCAN CAPABILITY CAT.#B7815F?

The FDA product code for G.E. SCAN CAPABILITY CAT.#B7815F 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 General Electric Co. as applicant

K103489GE VEO RECONSTRUCTION OPTION K082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION K081921GE VIVID E9 ULTRASOUND K073297GE LOGIQ P6 K072952GE ECHOPAC K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

View all 254 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.