FDA 510(k)

GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM

K-Number: K030199 · 2003-02-11

Decision Date2003-02-11

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM 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 2003-02-11 under 510(k) number K030199. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM?

GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is General Electric Co.. The 510(k) number is K030199.

When did GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM receive FDA 510(k) clearance?

GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM received FDA 510(k) clearance on 2003-02-11, under 510(k) number K030199.

Who is the listed applicant for GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM?

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 GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM?

The FDA product code for GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM is KPS.

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: KPS)

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.