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QuantorView 1.2.1.466

by Digiray Corp.

QuantorView 1.2.1.466 is a Class II device made by Digiray Corp., cleared under FDA 510(k) K151687 on 3 Aug 2015 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 08809466041112), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K151687

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809466041112 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151687 Date3 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151687 decided 3 Aug 2015 Active
  • FDA GUDID UDI-DI 08809466041112 listed 1 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151687
  2. Listed FDA GUDID 08809466041112

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
QuantorView
Generic name
Radiological PACS-dedicated management software
Model / reference
1.2.1.466
Primary DI / UDI-DI
08809466041112
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

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Other devices filed under Radiological PACS software.

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Properties

Other properties (15, all answered No)