MaxFOV 2
K-Number: K203617 · 2021-03-02
ApplicantGe Medical Systems, LLC
Decision Date2021-03-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MaxFOV 2 is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-03-02 under approval number K203617. 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 MaxFOV 2?
MaxFOV 2 is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K203617.
When was MaxFOV 2 approved by the FDA?
MaxFOV 2 received FDA 510(k) clearance on 2021-03-02, under approval number K203617.
What company makes MaxFOV 2?
MaxFOV 2 is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for MaxFOV 2?
The FDA product code for MaxFOV 2 is JAK.
Other Devices by Ge Medical Systems, LLC
Related Devices (Code: JAK)
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.
K163213Revolution CTGe Medical Systems, LLC
K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.
K160723OnSight 3D Extremity SystemCarestream Health, Inc.
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.
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.