Diagnosys CERTIFICATES
Diagnosys’ products are designed and manufactured to the highest standards of quality and compliance.
Diagnosys LLC is an ISO 13485:2016 / MDSAP certified corporation with FDA-registered medical device establishment. Diagnosys’ systems are CE marked and FDA 510(k) cleared and also has products installed worldwide with country specific medical device approvals where required. All Diagnosys systems are RoHS compliant as well as ETL marked.
MDSAP Certificate
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Diagnosys LLC has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of:
- ISO 13485:2016
- Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6)
- Canada: Medical Devices Regulations – Part 1- SOR 98/282
- United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)
- Japan: MHLW Ministerial Ordinance 169, Article 4 to Article 68; PMD Act
EC Certificate
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Diagnosys LLC’s full quality assurance system has been certified by Intertek SEMKO AB (0143), a Notified Body according to Directive 93/42/EEC on medical devices. Â Conforming to Directive 93/42/EEC on Medical Devices, Annex II excluding (4) entitles Diagnosys LLC to use the CE Mark on our electrophysiology equipment.
Diagnosys PATENTS
Combined Stimulator and Bipolar Electrode Assembly for Mouse Electroretinography (ERG)Â
US Patent No.: US 10,820,824
Date of Patent: Nov. 3, 2020
Abstract: Apparatus for evoking and sensing ophthalmic physiological signals in an eye, the apparatus comprising: an elongated tubular light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroid recess; an active electrode having a distal end and a proximal end, the active electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the active electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; and a reference electrode having a distal end and a proximal end, the reference electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the reference electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; wherein the distal end of the active electrode is located closer to the longitudinal axis of the elongated tubular light pipe than the distal end of the reference electrode.
Combined Stimulator and Electrode Assembly for Mouse Electroretinography (ERG)
Patent No.: US 11,357,442
Date of Patent: June 14, 2022
Abstract: Apparatus for evoking and sensing ophthalmic physiological signals in an eye, the apparatus comprising: an elongated light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroidal recess; and an electrode having a distal end and a proximal end, the electrode being mounted to the elongated light pipe and extending proximally along the elongated light pipe so that the distal end of the electrode terminates at the sphe roidal recess at the distal end of the elongated light pipe.
Electrically Evoked Response (EER) Stimulator / Amplifier Combination
US Patent No.:Â US 11,497,911
Date of Patent: Nov. 15, 2022
Abstract: Apparatus for ophthalmic electrophysiological testing, the apparatus comprising: an EER stimulator for providing an electrical stimulus to an eye so as to evoke an electrophysiological response, where in the EER stimulator comprises a power source; an amplifier for receiving the electrophysiological response and measuring that response, wherein the amplifier is integrated with the EER stimulator; and at least one switch disposed between the power source and the amplifier for isolating the power source from the amplifier when the electrical stimulus is delivered to the eye.
Method and Apparatus for the Assessment of Electrophysiological Signals
US Patent No.:Â US 10,893,823
Date of Patent:Â Jan. 19, 2021
Abstract:Â Apparatus for the assessment of electrophysiological signals obtained from a patient, the apparatus comprising: a housing; a support arch pivotally mounted to the housing, the support arch comprising a plurality of facial contact point supports for supporting contact points on the face of the patient relative to the support arch without supporting the chin of the patient; at least one display screen for presenting a stimulus to a single eye of the patient, the at least one display screen being movable relative to the support arch; and control electronics disposed within the housing for driving the at least one display screen and for amplifying electrophysiological signals obtained from the patient.
Country: Japan
Method and Apparatus for the Assessment of Electrophysiological Signals
Patent No.: 6,796,642
Date of Patent: 2020
Abstract:Â Apparatus for the assessment of electrophysiological signals obtained from a patient, the apparatus comprising: a housing; a support arch pivotally mounted to the housing, the support arch comprising a plurality of facial contact point supports for supporting contact points on the face of the patient relative to the support arch without supporting the chin of the patient; at least one display screen for presenting a stimulus to a single eye of the patient, the at least one display screen being movable relative to the support arch; and control electronics disposed within the housing for driving the at least one display screen and for amplifying electrophysiological signals obtained from the patient.
Combined Stimulator and Bipolar Electrode Assembly for Mouse Electroretinography (ERG)Â
US Patent No.: US 10,820,824
Date of Patent: Nov. 3, 2020
Abstract: Apparatus for evoking and sensing ophthalmic physiological signals in an eye, the apparatus comprising: an elongated tubular light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroid recess; an active electrode having a distal end and a proximal end, the active electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the active electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; and a reference electrode having a distal end and a proximal end, the reference electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the reference electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; wherein the distal end of the active electrode is located closer to the longitudinal axis of the elongated tubular light pipe than the distal end of the reference electrode.
Combined Stimulator and Electrode Assembly for Mouse Electroretinography (ERG)
Patent No.: US 11,357,442
Date of Patent: June 14, 2022
Abstract: Apparatus for evoking and sensing ophthalmic physiological signals in an eye, the apparatus comprising: an elongated light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroidal recess; and an electrode having a distal end and a proximal end, the electrode being mounted to the elongated light pipe and extending proximally along the elongated light pipe so that the distal end of the electrode terminates at the sphe roidal recess at the distal end of the elongated light pipe.
Electrically Evoked Response (EER) Stimulator / Amplifier Combination
US Patent No.:Â US 11,497,911
Date of Patent: Nov. 15, 2022
Abstract: Apparatus for ophthalmic electrophysiological testing, the apparatus comprising: an EER stimulator for providing an electrical stimulus to an eye so as to evoke an electrophysiological response, where in the EER stimulator comprises a power source; an amplifier for receiving the electrophysiological response and measuring that response, wherein the amplifier is integrated with the EER stimulator; and at least one switch disposed between the power source and the amplifier for isolating the power source from the amplifier when the electrical stimulus is delivered to the eye.
Method and Apparatus for the Assessment of Electrophysiological Signals
US Patent No.:Â US 10,893,823
Date of Patent:Â Jan. 19, 2021
Abstract:Â Apparatus for the assessment of electrophysiological signals obtained from a patient, the apparatus comprising: a housing; a support arch pivotally mounted to the housing, the support arch comprising a plurality of facial contact point supports for supporting contact points on the face of the patient relative to the support arch without supporting the chin of the patient; at least one display screen for presenting a stimulus to a single eye of the patient, the at least one display screen being movable relative to the support arch; and control electronics disposed within the housing for driving the at least one display screen and for amplifying electrophysiological signals obtained from the patient.
Country: Japan
Method and Apparatus for the Assessment of Electrophysiological Signals
Patent No.: 6,796,642
Date of Patent: 2020
Abstract:Â Apparatus for the assessment of electrophysiological signals obtained from a patient, the apparatus comprising: a housing; a support arch pivotally mounted to the housing, the support arch comprising a plurality of facial contact point supports for supporting contact points on the face of the patient relative to the support arch without supporting the chin of the patient; at least one display screen for presenting a stimulus to a single eye of the patient, the at least one display screen being movable relative to the support arch; and control electronics disposed within the housing for driving the at least one display screen and for amplifying electrophysiological signals obtained from the patient.
Diagnosys TRADEMARKS
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Celeris |
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Espion |
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Diagnosys FST |
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