Ultreon™ 1015310

GUDID 05415067047694

2.0 Software Upgrade Kit

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system

• Primary Device ID: 05415067047694
• NIH Device Record Key: 6c423fec-316b-45f8-889d-522ff64802d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultreon™
• Version Model Number: 1015310
• Catalog Number: 1015310
• Company DUNS: 018493531
• Company Name: LIGHTLAB IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067047694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210458

FDA Product Code

• NQQ: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-29

Devices Manufactured by LIGHTLAB IMAGING, INC.

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• 05415067047694 - Ultreon™: 2024-04-08 2.0 Software Upgrade Kit
• 05415067048882 - AptiVue™: 2023-10-09 Imaging Software Upgrade Kit
• 05415067030856 - AptiVue™: 2020-11-03 Software Upgrade Kit
• 00183739000678 - ILUMIEN™: 2019-02-11 Imaging System
• 00183739000937 - OPTIS™: 2019-02-11 Imaging System
• 00812059021420 - OPTIS™: 2019-02-11 Imaging System
• 00183739000562 - C7 Dragonfly™: 2018-03-29 Imaging Catheter
• 00183739000623 - Dragonfly™: 2018-03-29 Imaging Catheter