ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410— 510(k) K853755

Clearance details

Applicant

Victoreen, Inc.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

1985-09-09

Decision date

1985-11-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carle Place, NY, US

• K261170 — BA-004CC2026-08-12
• K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER1998-11-19
• K974112 — VACUDAP, MODEL 2000, 20011998-01-29
• K973960 — MODEL 37-1851998-01-14
• K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-7051997-07-21
• K964785 — VERIDOSE DIODES1997-06-13

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →