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Administration


USFoodDrug10903 NewHampshireAvenueDoc ID 040170420SilverSpringMD20993wwwfdagovNiCo-Lab BVNovember 20 2020 Roujuan ZhangConsultantMD Squared BVHigh Tech Campus 29Eindhoven 5858AENETHERLANDSRe K200873T

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1 U.S. Food & Drug Administration
U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.20 Silver Spring, MD 20993 www.fda.gov NiCo - Lab B.V. November 20, 2020 ℅ Roujuan Zhang Consultant MD Squared B.V. High Tech Campus 29 E indhoven , 5858AE N ETHERLANDS Re: K200873 Trade/Device Name: HALO Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological c omputer a ided t riage nd n otification s oftware Regulatory Class: Class II Product Code: QAS Dated: October 1, 2020 Received: October 5, 2020 Dear Roujuan Zhang: We have reviewed your Section 510(k) premarket notificati on of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not requ

2 ire approval of a premarket approval ap
ire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notifica tion Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Ac t include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affect Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federa

3 l Register . Please be advised that
l Register . Please be advised that FDA's issuance of a substantial equivale nce determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part K200873 - Roujuan Zhang Page 2 801); medical device reporting (reporting of medical device - related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpa rt B) for combination products (see https://www.fda.gov/combination - products/guidance - regulatory - information/postma rketing - safety - reporting - combination - products ); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination product s; and, if applicable, the electronic product radiation control provisions (Sections 531 - 542 of the Act); 21 CFR 1000 - 1

4 050. Also, please note the regulatio
050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.go v/medical - devices/medical - device - safety/medical - device - reporting - mdr - how - report - medical - device - problems . For comprehensive regulatory information about medical devices and radiation - emitting products, including information about labeling regulations, plea se see Device Advice ( https://www.fda.gov/medical - devices/device - advice - comprehensive - regulatory - assistance ) and CDRH Learn ( https://www.fda.gov/training - and - continuing - education/cdrh - learn ). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website ( https://www.fda.gov/medical - devices/device - advice - comprehensive - regulatory - assistance/contact - us - division - industry - and - consumer - education - dice ) for more information or contact DICE by email ( DICE@fda.hhs

5 .gov ) or phone (1 - 800 - 638 - 2041 or
.gov ) or phone (1 - 800 - 638 - 2041 or 301 - 796 - 7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure FORM FDA 3881 (7/17) Page 1 of 1PSC Publishing Services (301) 443-6740 EFDEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationIndications for Use Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. 510(k) Number (if known)K200873 Device NameHALO Indications for Use (Describe)HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify b y the medical specialist. HALO is indicated for CT scanners from GE Healthcare. Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARA

6 TE PAGE IF NEEDED. This section applies
TE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete of this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.govAn agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "#$%&'!()**+,- !"#$%&'$("'$)*! "#$%&! +",-."/#-'$'*! +&#x!'=!;&#x!'=!;5##6&7897:;7)C&7!+7A&7$:#DB6 01,#"/#%&$'21,*! "7$7:!2.7$6-EF�5&.D7G!HIE !$34/$*! C$#B7!+#@7G ! "#$% -:#66LNL%#AL.D!+#@7G &'()*+*,)-'+!.*/01234#66)6623(!74)',3!'8(!9*2):)-'2)*8!;*:243 -:#66LNL%#AL.D! O7 ! �=!.?&!@A=B=C@C -:#66LNL%#AL.D!5#D7:G ! &'()*+*,D P79L%7!-:#66G ! .+'66!EE 5$L

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