← Back to catalogue

Table

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref SW-TST-902Model 9510(k) K140093

by Anatomage, Inc.

Identity

Trade Name
Table EUDAMEDFDA UDI
Generic Name
Radiology information system application software FDA UDI
Device Name
Table EUDAMED
Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, educators, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes. FDA UDI
Model / Reference
9 EUDAMED
SW-TST-902 EUDAMED
9.0 FDA UDI
Description
Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, educators, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes. FDA UDI

Identifiers

Primary DI / UDI-DI
00852060007259 EUDAMEDFDA UDI
Basic UDI-DI
0852060007Table9G3 EUDAMED
Direct Marketing DI
00852060007259 EUDAMED
510(k) Number
K140093 FDA UDI
FDA Product Code
LLZ FDA UDI
EMDN Code
Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
Radiology information system application software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Table by Anatomage, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Anatomage, Inc.
EUDAMED SRN
US-MF-000027423
Authorised Representative
Freyr Regulatory GmbH DE-AR-000047121

Sources (3)

  • EUDAMED e45b6dbc-72ba-4a1d-8eba-c1478b0e5750 85 fields · synced Jun 18, 2026
  • FDA UDI 1ed828fb-8384-49fa-927c-3cf37742ab31 34 fields · synced May 30, 2026
  • FDA 510(k) K140093 1 fields · synced May 18, 2026