# K961459: Level 10 Hdi

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laboratories, Inc.
- Decided: Mar 26, 1997 after 344 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,077 later devices descend from it; 16 cite it directly.
3 of 1,078 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ATL HDI 3000 diagnostic ultrasound system: named in the summary without a submission number
- (no number) Storz Renaissance A/B Scan: named in the summary without a submission number

## Most influential descendants
- K034003: Hdi 5000 Diagnostic Ultrasound System (2004), 677 descendants of its own
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Indications for use
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations using Level 10 HDI are: General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Monitoring of cardiac function during procedures using transesophageal echocardiography. Biopsy guidance for tissue or fluid sampling. Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery Study of myocardial function in adults Study of eye anatomy including blood flow in retinal vessels and branches Study of the esophagué, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe Study of abdominal and pelvic organs and masses using laparoscopic probe Examination of organs, masses and vessels during surgical procedures Study of muscles, ligaments, nerve bundles and connective tissue

Source page: https://510kreport.com/device/K961459
Methodology: https://510kreport.com/methodology