Radiology · 510(k) · 2018
DR 800 with MUSICA Dynamic
Agfa HealthCare N.V.. Cleared by FDA on 5 April 2018 under submission K180589, product code JAA (system, x-ray, fluoroscopic, image-intensified). What FDA's record says, in FDA's words.
Device record · K180589
- Device. DR 800 with MUSICA DynamicDEVICE
- Company. Agfa HealthCare N.V. (BE)COMPANY
- Decision. 5 April 2018, 510(k), substantially equivalent (traditional review); received 6 March 2018DECISION
- Panel. RadiologyPANEL
- Product code. JAA, System, X-Ray, Fluoroscopic, Image-IntensifiedCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: x Positioning fluoroscopy procedures x Gastro-intestinal examinations x Urogenital tract examinations x Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications. NOTE: The mammography applications embedded in the MUSICA software are for previously cleared CR imaging applications (K081963) and not intended for DR or fluoroscopic imaging. Furthermore, the additional mammography software is only available through additional license keys that must be purchased. These licenses are only available outside of the USA. Agfa HealthCare NV Premarket Notification: DR 800 with MUSICA DynamicTM 5 - 5
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionstriage or notification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 90,614 reports filed against devices carrying product code JAA. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · CombiDiagnost R90 · Philips Medical Systems DMC GmbH · report 3003768251-2026-100040
It was reported that the detachable foot table board was broken and would not attach to the table due to physical damage. The device was not in clinical use, and there was no patient or user harm.
15 September 2026 · Malfunction · ProxiDiagnost N90 · Philips Medical Systems DMC GmbH · report 3003768251-2026-100031
It was reported that the X-ray machine was experiencing intermittent drive errors. The device was in clinical use and there was no patient or user harm.
11 September 2026 · Malfunction · ProxiDiagnost N90 Rel 1.1 · Philips Medical Systems DMC GmbH · report 3003768251-2026-100030
It was reported that during a swallow study with the unit in the upright position, the footboard cracked while the patient was standing on it. The device was in clinical use and there was no patient or user harm.
11 September 2026 · Malfunction · FLUOROSCOPY MACHINE · UNKOWN · report MW6002234
The marathon catheter used in the case was stuck in the brain due to the glue used for embolization. Dr took his time to try and removed the catheter. He was able to remove it but informed me that an end piece of the catheter (about 1 cm) broke off and stuck in the patient's common carotid artery. At the same time as the removal of the stuck catheter, the fluoroscopy machine malfunctioned, and we were forced to reboot the system. This caused Dr. to have to remove his remaining catheters and […]
10 September 2026 · Other · GE OEC C ARM · report MW6002099
C arm stopped working during surgery--image became pixelated and unable to accesspatient information.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JAA, in Radiology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.