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INTUITIVE SURGICAL INC

ION · Radiology

510(k): 10 Recall: 6 UDI: 8 MAUDE: 10 Class.: 60

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510(k) Clearances (10)

Ion Endoluminal System (IF1000)
2025-09-23

Substantially Equivalent

Ion Endoluminal System (IF1000)
2025-09-05

Substantially Equivalent

Ion Endoluminal System (IF 1000)
2024-09-24

Substantially Equivalent

Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
2024-04-03

Substantially Equivalent

Ion Endoluminal System (IF1000)
2023-12-18

Substantially Equivalent

Ion Endoluminal System (IF1000)
2022-06-16

Substantially Equivalent

Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
2021-08-26

Substantially Equivalent

Ion Endoluminal System
2020-11-16

Substantially Equivalent

Ion Endoluminal System
2020-06-26

Substantially Equivalent

Ion Endoluminal System
2019-11-26

Substantially Equivalent

Recalls (6)

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that
2025-12-04

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Ion Endoluminal System, REF: 380748-65
2024-07-12

There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
2021-08-06

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV
2020-10-23

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
2020-06-10

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
2020-06-10

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

UDI Registrations (8)

Ion Tomosynthesis Board

NA

Ion

Catheter

Ion

Vision Probe

Ion

System Cart

Ion

Controller

Ion

Vision Probe

Ion

Catheter

Ion

None

MAUDE Adverse Events (10)

Injury
20201023
Injury
20200918
Injury
20200918
Death
20200904
Injury
20200825
Injury
20200814
Injury
20200804
Injury
20200602
Injury
20200410
Injury
20200311

FDA Classification (60)

Processor, Cine Film

Radiology

Hydrogel Spacer

Radiology

Cassette, Measurement, Ardran-Crooks

Radiology

Assembly, Tube Housing, X-Ray, Therapeutic

Radiology

Generator, Orthovoltage, Therapeutic X-Ray

Radiology

Cabinet, X-Ray System

Radiology

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

Camera, Multi Format, Radiological

Radiology

System, Imaging, Holography, Acoustic

Radiology

Film, Radiographic

Radiology

Counter, Whole Body, Nuclear

Radiology

Holder, Syringe, Lead

Radiology

Processor, Radiographic-Film, Automatic, Dental

Radiology

Camera, X-Ray, Fluorographic, Cine Or Spot

Radiology

System, Therapeutic, X-Ray

Radiology

Display, Diagnostic Radiology

Radiology

Radiation Therapy Marking Device

Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

Radiology

System, Nuclear Magnetic Resonance Imaging

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Analyzer, Medical Image

Radiology

Dosimeter, Ionizing Radiation, Implanted

Radiology

Solid State Fluoroscopic X-Ray Imager

Radiology

Processor, Radiographic-Film, Automatic

Radiology

Test-Pattern, Radiographic

Radiology

Densitometer, Bone

Radiology

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Radiology

Radiological Software Device To Predict Future Breast Cancer Risk

Radiology

Device, Beam Limiting, X-Ray, Diagnostic

Radiology

Prostate Immobilizer Rectal Balloon

Radiology

Device, Communications, Images, Ophthalmic

Radiology

System, X-Ray, Mammographic

Radiology

Chair, Pneumoencephalographic

Radiology

Phantom, Anthropomorphic, Radiographic

Radiology

Changer, Radiographic Film/Cassette

Radiology

System, Applicator, Radionuclide, Remote-Controlled

Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Radiology

Needle, Isotope, Gold, Titanium, Platinum

Radiology

Shield, Gonadal

Radiology

Source, Teletherapy, Radionuclide

Radiology

System, Image Processing, Radiological

Radiology

Arthrogram Tray

Radiology

Tube Mount, X-Ray, Diagnostic

Radiology

Device, Digital Image Storage, Radiological

Radiology

Post Breast Biopsy Hemostatic Breast Compression Device

Radiology

Collimator, Low Voltage, Therapeutic X-Ray

Radiology

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology

Source, Isotope, Sealed, Gold, Titanium, Platinum

Radiology

Table, Radiologic

Radiology

System, Applicator, Radionuclide, Manual

Radiology

Programmer, Changer, Film/Cassette, Radiographic

Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Radiology

Holder, Radiographic Cassette, Wall-Mounted

Radiology

Radiographic Contrast Tray

Radiology

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

Automated Radiological Image Processing Software

Radiology

System, Imaging, X-Ray, Electrostatic

Radiology

Coil, Magnetic Resonance, Specialty

Radiology

Device, Spot-Film

Radiology