ALOKA ARIETTA 850

K173739 · Hitachi Healthcare Americas Corporation · IYN · Feb 28, 2018 · Radiology

Device Facts

Record IDK173739
Device NameALOKA ARIETTA 850
ApplicantHitachi Healthcare Americas Corporation
Product CodeIYN · Radiology
Decision DateFeb 28, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1550
Device ClassClass 2
AttributesPediatric

Intended Use

The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, and gastro-intestinal (GI) endoscopic clinical applications.

Device Story

ALOKA ARIETTA 850 is a multi-functional ultrasound diagnostic scanner; utilizes linear, convex, radial, and phased array probes to acquire ultrasound images. Operates by emitting ultrasound pulses into tissue and analyzing reflected echoes. Features include B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, eFlow, TDI, 3D, and 4D imaging. Used in clinical settings (OR, clinic) by trained personnel (physicians, sonographers). Employs adaptive filters (HI REZ) to enhance image quality. Output displayed on-screen for diagnostic evaluation; assists clinicians in visualizing internal structures, blood flow, and tissue characteristics to inform clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data required. Substantial equivalence is supported by bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety testing in conformance with AAMI/ANSI/IEC/ISO standards.

Technological Characteristics

Multi-functional ultrasound scanner; PC-based architecture using Windows OS. Supports linear, convex, radial, and phased array probes. Scanning methods: Linear, Convex, Sector, Radial, Trapezoidal. Digital signal processing; adaptive filters (HI REZ). Connectivity: Standard ultrasound system interfaces. Biocompatibility per ISO 10993. Safety standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2.

Indications for Use

Indicated for diagnostic ultrasound evaluation of fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal, musculoskeletal, wound, gynecological, cardiac, peripheral vessel, and GI endoscopic applications in adult and pediatric patients.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ February 28, 2018 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Hitachi Healthcare Americas Corporation % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087 Re: K173739 Trade/Device Name: ALOKA ARIETTA 850 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 12, 2018 Received: February 15, 2018 Dear Mr. Thistlethwaite: We have reviewed vour Section 510(k) premarket notification 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 require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ (1-800-638-2041 or 301-796-7100). 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | नव | PSC. 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(Superfic.) | | | | | | | | | | | | Other (Wound) | | | | | | | | | | | | Other (Gynecological) | | | | | | | | | | | | Other (Endoscopic) | | | | | | | | | | Cardiac | | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Peripheral vessel | Trans-esophageal (Adult/Pediatric) | | | | | | | | | | | | Peripheral vessel | | | | | | | | | ် မြောင်းများ၊ မြောက်မြို့နယ်၊ မြောက်တွင် ကျား ၁၇ ဦး၊ မ ၂၂၂ ဦး၊ လူဦးရေ စုစုပေါင်း ၂၇ ဦး၊ မ ၂၂၂ ဦး၊ လူဦးရေ စုစုပေါင်း ၂၇ ဦး၊ မ ၂၂၂ ဦး၊ လူ ### Additional Comments. :"s" idinsqus (sissimsonums guibuloui) ຂວາມງາມປະຕິທິນສຸລິຍາ ເພາະສາລາວລິດ ແລະມະນາກົງ 10 ສົມເຮັກຕັ້ງ ແລະ ສາມາດເຫຼ່ :"d" tqirosqus vissius guinning pasodxa semportus pur surgemi sebulan (ราทท่องอาณ วเด็กวรรดินธุ์ ້າງ, ງາມນາຣຸຖາຣ sined bus , munoros , sessed , bio.valiened , pio.net , propose , proposes , ്‍..p,, 1diusqng sdoid to asuebing 101 Builleui pue 'sinied 'mmoros 'issend 'pionythis.red 'pionyth sophilou ə, 10100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 vsqoid letser-suen to asusping 101 guigami sabulon subscriptions vsqoid โรนที่รู้ธง-รนหาว 10 ออนเร็กที่ 2017 ลูกเรียนที่ 25 มกราคม , მ, 1duosqng For Adult and the perfitative patients վ,, 1dirosqng spunow snourieves-noN/snouraviso 101 guigemi sabulon subscript "i ans and suipanorus bas 10811 Isuites in 101 gaigsmi sebulan (601.108 ЯНЭ IZ чэЧ) (ЛИО ЭгЛ иолицийн сэлЯ {6}------------------------------------------------ # 058 ATTEIЯA АХОДА :SmsM ээivэ П suasducer: C2251 swollot se ybod usund ath to sizylsus wolf birll 10 gaigemi bunoserthu sinsongsid :esu bobnetul | ləssə V İstərliqi sə | | sipis?<br>Info A spibili | | | ther (Wound | .ləxks-olunasın | | | superines | Buig6v-subi | istosi-suer | ərin cinsinə aid bitki növü. İstinadlar Cəmin Cəmin fəsiləsinə cinsinə aid bitki növü. İstinadlar Cəmin Cəmin Cəmin fəsiləsinə cinsinə aid bitki növü. İstinadlar | ərindən ilk Cənubə Filmləri | | əsinə aid bitki növü. İstinadlar Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər Şəhər | ാന്‍റോട്ടാവുമും | | | ອນເຊິນເມຣິເນຊັນແປງ ເສັ້ນປີ ທິລິສັງ ສິນເວີຍນທີ່ ເສັ້ນປີ ທິລິສັງ ສິ<br>summopqy | TELEF | imilsunyda<br>imlsdiriqo | | | oitsoildqA lsoini | |----------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------|----------------------|--------------------|-------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------|-------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|---------------------|------------------------------------------------------------------------------------|-------|--------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | 178-M33 M-M32 8-M32 8-M32 M31 MB AB Talong Time C 801 LT Mit bases Tasary Home » Marini Mari | าวรเมริกันที่มีความเมริกา ( เรื่อระหว่างวัล ) เรื่อง ( เรื่อง ( | | ərin (Economa) 1941 | ther (Gynesologica | | Superfor | əsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinin fəsiləsinin fəsiləsinə cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmlərində film | sussessont. (non-Cad | | | | | | one (Ones Special | | | trapperatives (Neuro | transperative (Spec | | | | าน & I อิตเวอร์นิเม & I | | | | | | | | | | | | | | | | | | Po | P | | | | Pa | P | | | B | | | | | | | | | | | | | | | | | Pd | P | | | | Pa | P | | | M | | | | | | | | | | | | | | | | | Pd | P | | | | Pa | P | | | and the provinsion of the provinsity of the provinsity of the provinsion of the provinsion of the provinsion of the provinsion of the provinsion of the provinsion of the prov | | | | | | | | | | | | | | | | | Pd | P | | | | s d | P | | | CWO | | | | | | | | | | | | | | | | | Pd | P | | | | દન | P | | spiddoc | | and the shop | | | | | | | | | | | | | | | | Po | P | | | | Pa | P | | ədə) pəuqquro | | | | | | | | | | | | | | | | | | Pd | P | | | | દન | P | | () | therer. ** | | אכש, CFM-B/CW 6 ระบบท วานอเมราะองุ ละพุ และบูร สินคริยม ### :suammo○ leuo!ippy - ..!,, idiaosqns ... ,, idiaosqng .. 3,, idiasqug ...ə., ıdırısqıns ...ə., idirəsqns :"6","diresque Posts institutions and ระราชออกแบบ สินทุกทาง () รอบทุวทาง Ssdoid 10 ອວບາ​ຍຸ​ນາ​​ຮີ 10 ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ sinə aid bitki növü. İstinadlar Respublikasının Filmin Filmin Filmin Filmin Filmin Film Sinfinin Sinfinin Sinfinin Sinfinin Sinfinin Sinfinin Sinfinin Film งระบบท โรแรงเรียก-รนหาว 10 ออนหรับเทร 101 สินที่สุริย์ที่ ระบบทางป vsdoid letter sure to asusping 101 guigami sepullan purpos than the singly one is second provinsion in the perior (รอมทุ่งออกมุ วเด็กวรรมหายัง ทุนย การรู้แมรงภาคต สินคุณภาพอ (601.108 ЯНЭ IZ чэд) (ljuQ эгүү иолдгиглэгчд รนธราง อินเขตบอลเมริ เทพ ประเทศ โรนทรวงกับ 101 รูแพรมนี ระบบไวต ະໜາດ {7}------------------------------------------------ # 058 ATTEIЯA АХОДА :SmsM ээivэ П ວັດວິສາຫະການປະກວດນາງ รพงไปปี ระ vbod นธทานป อปี 10 รัเรเรนเธพงใช้ biolit 10 ลิตเรียนที่ 1 วันเกราะประเทศ เรื่องเรนที่ | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) | | Ophthalmic | Ophthalmic | P | P | P | P | P | P | | | Fetal Imaging<br>& Other | Fetal | Pa | Pa | Pa | Pa | Pa | Pa | | | | Abdominal | | | | | | | | | | Intra-operative (Spec.) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | P | P | P | P | P | P | | | | Pediatric | | | | | | | | | | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Other (Wound) | | | | | | | | | | Other (Gynecological) | | | | | | | | | | Other (Endoscopic) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Adult/Pediatric) | | | | | | | | | | Peripheral vessel | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | ระบาท ### :sɪuəwuuo○ leuonippy ն, դեկշsqng , მ,, դժաշsqng ...ə., ıdırısqıns ...ə., idirəsqns :"6","diresque Posts institutions and (sissumooiuur aupunys pur surgao luuuuopat jo /sdoid suosuremaad jo saugust sapuluur sampun vsqoid letser-suert to asusping 101 guigami sebulan sdoid 10 ລວມ​ຍຸ​ນາ​​ຮີ 10 ສິ​ແຂ້​ຂະ​ແມ່ pur 'siued 'ພາ​ບາ​ດ​ນາ​ວາ​​ ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ v.rəsinə güirin bəsodxə səminən bura surasın 10 Bulğamı səphilən sinə aid bitki növü. İstinadlar Respublikasının Filmin Filmin Filmin Film Sinfinin S งระบบท โรแรงเรียก-รนหาว 10 ออนหรับเทร 101 สินที่สุริย์ที่ ระบบทางป purpos than the singly one is second provinsion in the perior (รอมทุ่งออกมุ วเด็กวรรมหายัง ทุนย การรู้แมรงภาคต สินคุณภาพอ (601.108 ЯНЭ IZ чэд) (ljuQ эгүү иолдвилгэчН top because the ราธราง อันเทพมานเทพ อาราศ โรนทราราชที่มีการรับ างใ รูปทรัพย์ รอบไวต ະໜາດ {8}------------------------------------------------ # 058 ATTEIЯA AXOTA :smsM ээivэ П ປີ ຄ.ສ. 2001 ເມືອງ 1992 ເປັນ ປີ 2005 ເປັນ ປີ 2000 ເປັນ ປະຕິທິນ ເປັນ 2000 ເປັນ ປະຕິທິນ ເປັນ 2000 ເປັນ ປະຕິທິນ ແລະ 2000 ເປັນ ປະຕິທິນ ເປັນ 2000 ເປັນ ເປັນ 2000 ເປັນ ເປັນ ເປັນ 20 swollof se ypod usunu att to sisvisus woll bird 10 gaigsmi bunosetti ... am bebreid | | റ്റ്സ്മാപ്പർ Issimi | | | | and of the Off on the store | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-----|--------|-----------------------------|-------------|---------------------| | | | B | M | WO CWS | | *bəniqquloq | | | (പ്രവർ I റ്റാല്പു) | วนี้เวอร์นิเวอร์นิเมวิช III x8 I ของราโ | | | | lological of o | | (.ວədç) « * * 1947) | | նական կարական կարևորներ է նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա նա | വന്ത്രിന്റെ വ്യാ | | | | | | | | | Tetal | P | P | P | P | P | P | | and the land the super was and on the first of the first of the first of the first of the first of the first of the first of the first and only of the first and of the first | summopqy | દન | s T | s T | દન | s T | દન | | | itsupperstitives (Spec. | | | | | | | | | tomations (Neuro | | | | | | | | | ാന്‍റ്റ് ടോട്ടാമുട | | | | | | | | | omsibəs | | | | | | | | | coals) usgar (Specifican | | | | | | | | | ərindən fəsiləsinə cinsinə aid bitki növü. İstinadlar Azərbaycan Filmin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəs | | | | | | | | | ədən filmləri Cəmin A | | | | | | | | | rans-recta | | | | | | | | | ន បាន នរបស់ នេះ ទាប់ នា | | | | | | | | | rupsun-suri | | | | | | | | | rans-essoph. (non-Card | | | | | | | | | ในอังกฤษ) .โอฟุร-อโมวรมไฟ | | | | | | | | | ວັນນາງງາມຊາວໄປວັນທີ (ອັນນາການ | | | | | | | | | ther (Wound | | | | | | | | | (Shar (Oynecologica | | | | | | | | | the sobre) the redit | | | | | | | | | InpA osibus | | | | | | | | Cardido | ordinas Pediatio | | | | | | | | | intsibe9/1/1ubA) โรครูธระดับบรระราชรา | | | | | | | | İstinadlar İstinadlar Şaman Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şama | ləssəs İstinadlar R | | | | | | | | | 198 MH2 M-M3DA-M37 A-M37 MB BB TelumO 100 J Me TV A 1 Porce of the Marketed does on order in 1 M | | | | | | | | | | | | | | | | พ พุทธศัพท์ พ.ศ. 1844 เพลง ### :susummon leuoinippA :"6" idinsquq รเรื่องคนที่ 2 มีนาคม 2019 บุคคลที่ 2017 ครั้ง 10 กรุงเทพ รัฐบาท 2017 คน รับเช่นที่ 10 สินทริยตที่ 30 สินทุธยนี้เ Transcript includes imaging of organs and structures that may be exposed during surgery. (samberond sidossonedal pur vissansoman guibulox siusd pur ,um40135 ,ssend ,pio.nfdfremed ,pio.nyth sepulsup loid to asuebing 101 Suiseuii pur 'siusd 'unhoros 'siesend 'pio.Nyt sophisul aoid lanison saart to sousping rol sainomi sabuloni (sqoid leuigen-sura) to sousbing 107 gaigsmi sabulon 01 sinə aid bir bir bir başların məşğul olunmuşdur. Bu mərkəzi və bir mənist # Description Non-cancerous (benign) conditions of the breast include infections, injuries, and other problems. Most women have benign breast conditions. In fact, these conditions are more common than breast cancer. Some benign breast conditions are linked to an increased risk of getting breast cancer later. This is especially true if th…
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