ApolloVue S100 Image System

Basic Information

• Brand Name: ApolloVue S100 Image System
• Primary DI: 04719878880008
• Version / Model: S100-000US
• Company Name: APOLLO MEDICAL OPTICS, LTD.
• Labeler DUNS: 656285971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-14
• Public Version: 2
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 646dfd4e-01a8-4e2b-835b-b74e1990d390

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58074	Dermatological optical coherence tomography system	An assembly of devices designed to use a broad-bandwidth light beam aimed via an applicator at a region of interest (ROI) on the surface of the skin for optical coherence tomography (OCT) to provide high-resolution images (e.g., above 1 micron) of the surface tissue in order to visualize skin morphology. It typically consists of a main unit with an operator's console, a computer for image storage, a hand-held or electromechanical probe (applicator), and a visual display unit (VDU). Reflected light is picked up by the probe that converts it into electrical signals. The computer and dedicated software provide cross-sectional images of the derma or two- or three-dimensional (3-D) volume scans.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719878880008	GS1