Radiology · 510(k) · 2022
Precise Image
Philips Medical Systems Nederland, B.V.. Cleared by FDA on 14 January 2022 under submission K210760, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K210760
- Device. Precise ImageDEVICE
- Company. Philips Medical Systems Nederland, B.V. (NL)COMPANY
- Decision. 14 January 2022, 510(k), substantially equivalent (traditional review); received 15 March 2021DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, Class IIREG
- Source. FDA database entry · decision document (8 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.
/ Intended Use: The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x -ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. Precise Image has been evaluated and available on preselected reference protocols for adult subjects. Precise Image is not indicated for use in pediatric subjects. The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging. Precise Image uses an Artificial Intelligence powered reconstruction algorithm that is designed for low radiation dose, provides low noise, and improves low contrast detectability.
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 namedCT, radiographs (X-ray)
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5,281 reports filed against devices carrying product code JAK. 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:
25 September 2026 · Malfunction · REVOLUTION EVO · GE MEDICAL SYSTEMS, LLC · report 50896044
The GE CT table wouldn't move during stroke. Patient had to be physically moved to resume scan, delay in care. GE CT table has had the same issues with the table working intermittently x 3 weeks. Multiple techs have worked on it and the same problem persists.
25 September 2026 · Malfunction · Needle Guide · Quantum Surgical SAS · report 3023140882-2026-00002
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00087
It was reported that during the procedure, one locatable guide indicated as outside of the sensor sensing volume and another locatable guide had difficulty retracting from the extended working channel. The physician completed the superDimension portion of the case. No patient complications have been reported as a result of this event.
23 September 2026 · Other · NL4000 · Samsung HME America, Inc. · report 3004938766-2026-00043
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00088
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 JAK, in Radiology, from Philips Medical Systems Nederland, B.V., or cleared in 2022. 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.