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Espion

FDA UDI

Class II (US FDA UDI)

by Diagnosys Llc

Identity

Trade Name
Espion FDA UDI
Generic Name
Electroretinograph FDA UDI
Device Name
Profile System; with Non-Xenon ColorDome and Mini OLED with extendable arm with table stand is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNS-N-X FDA UDI
Profile System; with 27" Monitor and Mini OLED on extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-B-1-27F-N-X FDA UDI
Profile System; with 23" Monitor and ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-23F-2-N FDA UDI
Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDXS-2-X FDA UDI
Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand & extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNS-2-B FDA UDI
The Profle System with Xenon ColorDome & ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). It's product configuration D310-R-1-CDXS-2-N. FDA UDI
Profile System; with Non-Xenon ColorDome and 220V Power Supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-2-CDNS-N-N FDA UDI
Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNS-2-X FDA UDI
Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNR-N-X FDA UDI
Profile System; with Non-Xenon ColorDome on OR Arm and Mini OLED with table stand is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNR-N-T FDA UDI
Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-5-CDXR-N-N FDA UDI
Model / Reference
D310 FDA UDI
Description
Profile System; with Non-Xenon ColorDome and Mini OLED with extendable arm with table stand is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNS-N-X FDA UDI
Profile System; with 27" Monitor and Mini OLED on extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-B-1-27F-N-X FDA UDI
Profile System; with 23" Monitor and ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-23F-2-N FDA UDI
Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDXS-2-X FDA UDI
Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand & extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNS-2-B FDA UDI
The Profle System with Xenon ColorDome & ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). It's product configuration D310-R-1-CDXS-2-N. FDA UDI
Profile System; with Non-Xenon ColorDome and 220V Power Supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-2-CDNS-N-N FDA UDI
Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNS-2-X FDA UDI
Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNR-N-X FDA UDI
Profile System; with Non-Xenon ColorDome on OR Arm and Mini OLED with table stand is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-CDNR-N-T FDA UDI
Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-5-CDXR-N-N FDA UDI

Identifiers

Primary DI / UDI-DI
00850594007769 FDA UDI
00855730007146 FDA UDI
00850594007356 FDA UDI
00850594007820 FDA UDI
00850594007905 FDA UDI
00850594007028 FDA UDI
00855730007252 FDA UDI
00850594007813 FDA UDI
00850594007783 FDA UDI
00850594007271 FDA UDI
00855730007276 FDA UDI
510(k) Number
K863956 FDA UDI
FDA Product Code
GWE FDA UDI
GMDN Term
Electroretinograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electroretinograph

Espion by Diagnosys Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroretinograph.

Cleared under the same submission

K863956 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnosys Llc

Sources (11)

  • FDA UDI 5bb22251-35e6-41a2-bdd8-024645634d05 35 fields · synced Jun 8, 2026
  • FDA UDI b74c23fe-f5bd-4ec3-919c-ce252691ee35 35 fields · synced May 25, 2026
  • FDA UDI e97e35cb-f8ed-4818-b99c-119a83d1144d 35 fields · synced May 25, 2026
  • FDA UDI a3e86081-924b-4f24-89e8-a41fbc1f5020 35 fields · synced May 25, 2026
  • FDA UDI fd2f829b-95be-4133-b245-2f03d873c9c3 35 fields · synced May 25, 2026
  • FDA UDI 8d59fafb-ea0b-4bb7-a1df-ed120e2f410f 35 fields · synced May 25, 2026
  • FDA UDI 92c56a70-819d-4c86-bde2-4f488fb13d0e 35 fields · synced May 25, 2026
  • FDA UDI d4ddb981-80f9-44f6-b2b0-7fa986cb56de 35 fields · synced May 25, 2026
  • FDA UDI f7fdc473-c48a-4152-8838-8c0dc81dce82 35 fields · synced May 25, 2026
  • FDA UDI ba9e1d5d-ef43-4daa-a421-31d30ff019c5 35 fields · synced May 26, 2026
  • FDA UDI 01e680d3-dc30-4b8e-a402-5aa842b699a2 35 fields · synced May 26, 2026