Radiology · 510(k) · 2019
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
Omega Medical Imaging, LLC. Cleared by FDA on 4 October 2019 under submission K191713, product code JAA (system, x-ray, fluoroscopic, image-intensified). What FDA's record says, in FDA's words.
Device record · K191713
- Device. CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)DEVICE
- Company. Omega Medical Imaging, LLCCOMPANY
- Decision. 4 October 2019, 510(k), substantially equivalent (traditional review); received 26 June 2019DECISION
- Panel. RadiologyPANEL
- Product code. JAA, System, X-Ray, Fluoroscopic, Image-IntensifiedCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (17 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 Om ega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-1 OOS as a modification device to provide an automated Region of interest that reduces exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscop ic appl ications including cardiac, vascular, general radiographic /fluoroscopic diagnostic, and interventional x-ray imaging for General Populations. At no time will the CA-1 OOS be considered as a replacement for the primary collimator. The primary collimat or shall always be u sed, in accordance with good medical practice, to define a Region of Interest CS-series-FP Radiographic I Fluoroscopic Systems with Optional CA-IOOS I FluoroShield (ROI Assembly) OF HEAL TH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. Indications for Use Traditional 510(k) Summary for Optional CA-100S / FluoroShield Region of Interest Device, Rev. 4 page-1 Traditional 510(k) SUMMARY Company Name: Omega Medical Imaging, LLC Address: 3400 St. Johns Parkway, Suite 1020, Sanford, Fl 32771 Telephone No: 407-323-9400 Registration No: 1052701 Contact person: John Newman (Manager of Regulatory Affairs) Date Prepared: 08/28/2019 Device (trade) name: CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA- 100S / FluoroShield (ROI Assembly) Common/usual name: Fluoroscopic/Radiographic X-ray system
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)
- Mentionsa diagnostic claim
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, from Omega Medical Imaging, LLC, or cleared in 2019. 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.