Vitrea

by Canon Medical Informatics, Inc. 9 variants

Part of a family of 10 devices: see the family page

Ref 7.16.3.SU01

Vitrea (7.16.3.SU01) is a device classified as Class IIa in the EU and Class II in the US made by Canon Medical Informatics, Inc., registered in EUDAMED on 20 Sep 2023 (Basic UDI-DI 0850025268VitreaAVES), cleared under FDA 510(k) K223261 on 13 Jul 2023 (18 earlier submissions) and listed in FDA GUDID since 24 Sep 2025 (UDI-DI 00850025268370), withdrawn (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026. 7 FDA recalls are linked to it.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223261

+18 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number00850025268370 UDI-DI	Date24 Sep 2025Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number0850025268VitreaAVES Basic UDI-DI 00850025268370UDI-DI	Date20 Sep 2023Registered	StatusWithdrawn No longer placed on the EU market
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK223261	Date13 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK222662	Date14 Oct 2022Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK181247	Date20 Nov 2018Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK182230	Date7 Sep 2018Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK172855	Date5 Oct 2017Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK161157	Date3 Nov 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK160150	Date16 Mar 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK151283	Date30 Oct 2015Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK151919	Date10 Oct 2015Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK150104	Date17 Apr 2015Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK143079	Date4 Dec 2014Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK141302	Date1 Aug 2014Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK140395	Date13 May 2014Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK122578	Date25 Feb 2013Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK121213	Date2 Nov 2012Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated	NumberK071362	Date30 May 2007Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated	NumberK071331	Date25 May 2007Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK052632	Date15 Dec 2005Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated	NumberK032748	Date29 Oct 2003Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 0850025268VitreaAVES — open Devices and search for it
AccessGUDID record UDI-DI 00850025268370
FDA 510(k) database 510(k) number K223261
FDA 510(k) database 510(k) number K222662
FDA 510(k) database 510(k) number K181247
FDA 510(k) database 510(k) number K182230
FDA 510(k) database 510(k) number K172855
FDA 510(k) database 510(k) number K161157
FDA 510(k) database 510(k) number K160150
FDA 510(k) database 510(k) number K151283
FDA 510(k) database 510(k) number K151919
FDA 510(k) database 510(k) number K150104

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 0850025268VitreaAVES registered 20 Sep 2023 Withdrawn
FDA 510(k) K223261 decided 13 Jul 2023 Active· +18 more in the status table
FDA GUDID UDI-DI 00850025268370 listed 24 Sep 2025 Listed

Recalls

7 recalls · FDA

- Terminated Z-0169-2014 FDA Class II initiated 21 Oct 2013
Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
- Terminated Z-1181-2013 FDA Class II initiated 15 Mar 2013
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
- Terminated Z-1144-2013 FDA Class II initiated 15 Mar 2013
Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.
- Terminated Z-0186-2013 FDA Class II initiated 13 Aug 2012
Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.
- Terminated Z-0388-2012 FDA Unclassified (pre-2012) initiated 11 Nov 2011
Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.
- Terminated Z-1021-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data
- Terminated Z-0520-2008 FDA Unclassified (pre-2012) initiated 8 Nov 2007
Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not up

Timeline

28 dated events

30 Oct 2015 Cleared FDA 510(k) K151283
16 Mar 2016 Cleared FDA 510(k) K160150
3 Nov 2016 Cleared FDA 510(k) K161157
5 Oct 2017 Cleared FDA 510(k) K172855
7 Sep 2018 Cleared FDA 510(k) K182230
20 Nov 2018 Cleared FDA 510(k) K181247
14 Oct 2022 Cleared FDA 510(k) K222662
13 Jul 2023 Cleared FDA 510(k) K223261
20 Sep 2023 Registered EUDAMED 0850025268VitreaAVES
24 Sep 2025 Listed FDA GUDID 00850025268370

18 earlier events are in the sections above.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Withdrawn
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Vitrea EUDAMED
Vitrea Advanced Visualization GUDID
Generic name: Radiological PACS-dedicated management software
Model / reference: 7.16.3.SU01

Primary DI / UDI-DI: 00850025268370
Basic UDI-DI: 0850025268VitreaAVES
Direct marketing DI: 00850025268370
510(k) Number: K032748
K052632
K071331
K071362
K121213
K122578
K140395
K141302
K143079
K150104
K151283
K151919
K160150
K161157
K172855
K181247
K182230
K222662
K223261
FDA product code: LLZ, JAK, LMD
EMDN code: Z110603 Picture archiving and communication systems
GMDN term: Radiological PACS-dedicated management software

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 892.2050, 892.1750, 892.2020
Special device type: Software
EU registration type: Standard device
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN: US-MF-000020013
Authorised representative: MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Canon Medical Informatics, Inc.

Vitrea Advanced Visualization 7.16.4

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Vitrea Advanced Visualization 7.16.4.SU01

Class II
Vitrea Advanced Visualization 7.16.4.SU02

Class II
Vitrea Advanced Visualization 7.16.3.SU03

Class II

See all devices from Canon Medical Informatics, Inc. →

Properties

Measuring function
Lot / batch number
Manufacturing date

Other properties (22, all answered No)