# K961073: Atlas 2.0 & Hitachi 2.0 (a Trade Name Subject to Change)

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Diagnostics Intl., Inc.
- Decided: Feb 19, 1997 after 338 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 later device descends from it; 1 cites it directly.
0 of 2 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) ATL Ultramark® 9 HDI™ diagnostic ultrasound system: named in the summary without a submission number
- (no number) Atlantis Atlas 1.0 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
- K060410: Echoheart Transvaginal Doppler Probe (2006), 0 descendants of its own

## Indications for use
Atlas 2.0/ Hitachi 2.0 are intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations shall include; General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies. Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall. Pediatric scans of organs. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility applications. First, second and third trimester pregnancy studies, Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal cephalic studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

Source page: https://510kreport.com/device/K961073
Methodology: https://510kreport.com/methodology