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Simpleware ScanIP M-2017.06

by Synopsys, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00863520000314 UDI-DI Date5 Jun 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2254-2021 FDA Class II initiated 4 Jun 2021
    • Terminated Z-2253-2021 FDA Class II initiated 4 Jun 2021

    A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Simpleware ScanIP
Generic Name
Radiology DICOM image processing application software
Model / Reference
M-2017.06
Primary DI / UDI-DI
00863520000314
510(k) Number
FDA Product Code
LLZ
GMDN Term
Radiology DICOM image processing application software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No