U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Medical charged-particle radiation therapy system - Product Code MUJ
원인
The new "dicom ct with body outline" method to create a patient case in preciseplan 2.15 may produce incorrect
results for some customers, given several input conditions encountered in the field. discontinue use of this method of
creating a patient case until fco 772 00 540 064, (entitled "update for patient creation method using dicom ct with body outline"), is received from elekta to update th.
조치
Important Notice A297, "PrecisePLAN release 2.15 with DICOM CT with Body Outline" method of patient creation (dated May 8, 2007) was distributed to all customers. An additional Field Change Order 540 073, dated September 30, 2008 was distributed to customers. Important Notice A316 "Cancellation of Important Notice for PrecisePLAN" was issued. The Important Notice instructed affected users to dispose of Important Notice A297 and replace it with Important Notice A316.
If you have any questions regarding the notification, please contact your local Elekta representative directly.
United States -- (AL, AK, AZ, AR, CA, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, , NC, OH, OK,OR, PA, SC, TN, TX, VA, WA and WI) & France.
제품 설명
PrecisePLAN 2.15 Treatment Planning System. || The product is used to plan multiple beam radiation therapy treatments.