FDA device listing

Collaboration Live

FDA device listing 1356270618 · Philips Medical Systems International BV

Key facts

Proprietary names Collaboration Live
Owner/operator Philips Medical Systems International BV
Owner/operator number 1217116
Premarket submissions K201665
Product codes IYN, IYO, LLZ
Device names IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, LLZ - System, Image Processing, Radiological
Device class Class II
Classification regulations (21 CFR) 892.1550, 892.1560, 892.2050
Review panels Radiology
Registered establishments Philips Electronics Ltd, Philips Global Business Services LLP - Ultrasound Business Unit, Philips India Limited - Ultrasound Business Unit, Philips Ultrasound LLC
Establishment registrations 3019216, 3000126629, 3017894900, 3033527241, 3033527283
FEI numbers 3019216, 3000126629, 3017894900, 3033527241, 3033527283
Establishment operations Complaint File Establishment, Specification Developer, Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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