Espion

FDA UDI

Class II (US FDA UDI)

by Diagnosys Llc

Identity

Trade Name: Espion FDA UDI
Generic Name: Electroretinograph FDA UDI
Device Name: E3 System; with Non-Xenon ColorDome and 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: D315-1-1-CDNSL-23-2-N FDA UDI
E3 System; with Non-Xenon ColorDome on an OR Stand 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: D315-1-1-CDNRL-NN-N-T FDA UDI
E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, 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: D315-5-1-2 FDA UDI
E3 Console, 32-bit amplifier, amplifier stand, portable computer with Espion Software and Accessory Kit 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: D315-3-1-R-1-P FDA UDI
E3 System; with Xenon ColorDome on an OR Stand and 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: D315-1-1-CDXRL-23-2-N FDA UDI
E3 System; with Xenon ColorDome on an OR Stand and 23" Monitor 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: D315-1-1-CDXRL-23-N-N FDA UDI
E3 System; with Non-Xenon ColorDome on an OR 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: D315-1-1-CDNRL-NN-N-N FDA UDI
Model / Reference: D315 FDA UDI
Description: E3 System; with Non-Xenon ColorDome and 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: D315-1-1-CDNSL-23-2-N FDA UDI
E3 System; with Non-Xenon ColorDome on an OR Stand 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: D315-1-1-CDNRL-NN-N-T FDA UDI
E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, 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: D315-5-1-2 FDA UDI
E3 Console, 32-bit amplifier, amplifier stand, portable computer with Espion Software and Accessory Kit 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: D315-3-1-R-1-P FDA UDI
E3 System; with Xenon ColorDome on an OR Stand and 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: D315-1-1-CDXRL-23-2-N FDA UDI
E3 System; with Xenon ColorDome on an OR Stand and 23" Monitor 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: D315-1-1-CDXRL-23-N-N FDA UDI
E3 System; with Non-Xenon ColorDome on an OR 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: D315-1-1-CDNRL-NN-N-N FDA UDI

Identifiers

Primary DI / UDI-DI: 00850594007578 FDA UDI
00850594007707 FDA UDI
00850594007714 FDA UDI
00855730007207 FDA UDI
00850594007622 FDA UDI
00850594007615 FDA UDI
00850594007516 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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.

RETeval™ — LKC Technologies · Class I
RETeval™ — LKC Technologies · Class I
RETeval™ — LKC Technologies · Class I
RETI-port/scan 21 alpha plus — Roland Consult Stasche & Finger GmbH · Class II
UTAS — LKC Technologies · Class II
UTAS — LKC Technologies · Class II
RETeval™ — LKC Technologies · Class I
RETI-port/scan 21 gamma — Roland Consult Stasche & Finger GmbH · Class II

Cleared under the same submission

K863956 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Diagnosys Llc

Sources (7)

FDA UDI 1f37880b-4d08-42c6-b727-a478abf5d218 35 fields · synced Jun 8, 2026
FDA UDI d7e60d4f-7025-49f3-b38f-a6ea4c482ec3 35 fields · synced May 22, 2026
FDA UDI 4beb61bc-2bab-4fd7-b52b-8f7c223c1a1d 35 fields · synced May 22, 2026
FDA UDI 4c4e67fb-a7c1-4596-ae46-ac6972189617 35 fields · synced May 24, 2026
FDA UDI e7b46a0b-f5c9-4d6b-ae55-71fff7e3062e 35 fields · synced May 24, 2026
FDA UDI b4f02dd0-2e40-4fb6-94bc-ffd30addcf04 35 fields · synced May 25, 2026
FDA UDI 8b0b88a9-1fb4-4445-b164-7203fae84c06 35 fields · synced May 27, 2026