DX-D 600— 510(k) K112670

Clearance details

Applicant

Agfa Healthcare N.V.

Product code

Code KPR

Device class

Class 2

Regulation

21 CFR 892.1680

Advisory panel

Radiology

Date received

2011-09-14

Decision date

2011-10-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Greenville, SC, US

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• K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
• K260481 — GC85A2026-08-27
• K260482 — DRE Duo2026-06-15
• K253446 — AeroDR TX c022026-04-10

• K252199 — AGFA HealthCare Enterprise Imaging2025-10-15
• K180589 — DR 800 with MUSICA Dynamic2018-04-05
• K172784 — DX-D Imaging Package2017-10-13
• K170434 — Enterprise Imaging XERO Viewer 8.12017-07-03
• K161368 — DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)2016-09-22

Other

6

Total

6

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 →

• Z-0692-2019 — DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.Class II·Terminated·Agfa-Gevaert, N.V.·20181204
• Z-3245-2018 — DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.Class II·Terminated·Agfa N.V.·20180815
• Z-1738-2017 — DX-D600 - DXD Imaging PackageClass II·Terminated·AGFA Healthcare Corp.·20160502
• Z-2175-2014 — DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.Class II·Terminated·AGFA Healthcare Corp.·20140702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112670.