DR 800 with MUSICA Dynamic
K180589Agfa HealthCare N.V. · cleared 2018-04-05 · product code JAA · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Agfa HealthCare's DR 800 is an image-intensified fluoroscopic x-ray system (product code JAA) intended to capture images of the human body. The DR 800 is a floor-mounted R/F system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA Dynamic™™ image processing and flat-panel detectors for digital and wide dynamic range image capture.”
source quote (p.5)
“The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are similar to those previously cleared and used in Agfa's radiography portfolio today which includes the DR 600 (K152639) and DR 400 (K141192). The addition of the dynamic image processing is identical to the predicate device (K140380).”
source quote (p.10)
“Agfa utilized the following guidance documents in the development of the DR 800 with MUSICA DynamicTM... Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software (January 2005)... Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2014)”
Validation studies (4)
Bench
sample size not stated
endpoints: Usability and functionality; Radiographic and fluoroscopic workflow support; Dynamic and static imaging; Continuous and rapid sequence exams; Calibration; Positioning
Bench
sample size not stated
endpoints: Mount stitch grid validation; Imaging ranges tolerance; Transversal collimation; Medical ruler exposure; Comparison to current FLFS software (equal to or better); FLFS landscape functional design meets user needs
Bench
n=2 other
endpoints: Level of dose control in adult and pediatric phantoms; Compliance with DIN-norm and dose limit curve
Bench
sample size not stated
endpoints: Image quality for pulsed and continuous fluoroscopy imaging (good and excellent); Suitability for diagnosis for MUSICA3 Abdomen+ images (higher image quality); Clinical acceptability for static images
standards: IEC 60601-1: 2012, IEC 60601-1-2: 2007, IEC 60601-1-3: 2008, IEC 60601-2-54: 2009, ISO 13485:2003, ISO 14971:2012, IEC 62304:2006, ISO 62366:2007, ACR/NEMA PS3.1-3.20: 2011
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code JAA (SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku, initiated 2024-09-06): "X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95450
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).