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RamSoft 6.0.5.5040

by Ramsoft Inc 4 variants

RamSoft 6.0.5.5040 (GWY6) is a Class II device made by Ramsoft Inc, cleared under FDA 510(k) K052460 on 21 Sep 2005 and listed in FDA GUDID since 31 Jan 2017 (UDI-DI B359GWY60), 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) K052460

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 NumberB359GWY60 UDI-DI Date31 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052460 Date21 Sep 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052460 decided 21 Sep 2005 Active
  • FDA GUDID UDI-DI B359GWY60 listed 31 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052460
  2. Listed FDA GUDID B359GWY60

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RamSoft
Generic name
Radiology picture archiving and communication system workstation
Model / Ref / Catalog
6.0.5.5040, GWY6
Primary DI / UDI-DI
B359GWY60
510(k) Number
FDA product code
LLZ
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)