BLADDERMANAGER PCI 5000 MODEL 1002— 510(k) K982568

Clearance details

Applicant

Diagnostic Ultrasound Corp.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

1998-07-23

Decision date

1999-01-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Redmond, WA, 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

• K030763 — DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM2003-03-26
• K022153 — BLADDERSCAN BVI 61002002-08-15
• K963585 — BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 50001996-10-01
• K955840 — BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 50001996-05-24
• K955942 — BLADDERSCAN BVI 50001996-03-15

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 →