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Notebook Clinic Viewer

by Surgical Theater LLC

Notebook Clinic Viewer is a surgical simulation system (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Surgical Theater LLC, cleared under FDA 510(k) K123023 on 8 Feb 2013 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00863157000343), active as of 1 Jun 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 1 Jun 2026

Documents

510(k) K123023

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00863157000343 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123023 Date8 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123023 decided 8 Feb 2013 Active
  • FDA GUDID UDI-DI 00863157000343 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123023
  2. Listed FDA GUDID 00863157000343

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Surgical simulation system
Model / reference
Notebook
Primary DI / UDI-DI
00863157000343
510(k) Number
FDA product code
LLZ
GMDN term
Surgical simulation system
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical simulation system

Cleared under the same submission (K123023)

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Surgical Theater LLC

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    Class II

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  • SRP BrainStorm

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See all devices from Surgical Theater LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)