DPD-12PCC— 510(k) K990734

Name: FDA 510(k) clearance K990734
Creator: U.S. Food and Drug Administration
Published: 1999-05-28

Substantially Equivalent

Scanditronix Medical AB

FDA 510(k) clearance K990734 for DPD-12PCC, Substantially Equivalent on 1999-05-28. Applicant: Scanditronix Medical AB. Device class: 2.

Clearance details

Applicant: Scanditronix Medical AB
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1999-03-05
Decision date: 1999-05-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Uppsala S-754 50, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYE

view all

K261865 — AerFrame Alignment Laser Box (LBV2)2026-09-16
K261718 — EZFluence (RADEZ V2)2026-08-31
K260733 — MRIA Radiation Therapy Information System (MRIA)2026-08-26
K261856 — Halcyon, Ethos Radiotherapy System (5.0)2026-08-03
K252937 — ThinkQA 32026-06-12

More clearances from Scanditronix Medical AB

view all

K011763 — OMNIDOS2001-09-05
K002051 — INVIDOS2000-09-05
K961400 — RFA-300, LDA UTILITY1997-01-03

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.