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Table 1 List of 3D modelling with the intended use of producing 3D printed anatomical models, cleared by the FDA (Class II 510(k) pathway)

From: Correction: Navigating the intersection of 3D printing, software regulation and quality control for point-of-care manufacturing of personalized anatomical models

Company

Software

Validated with Specific

3D Printers

Intended for Diagnostic Use

Intended Use Applications

Validation Accuracy

Reference

Orthopaedic

(Cranio) Maxillofacial

Cardiovascular

Gastrointestinal

Genitourinary

Neurological

Materialise

Mimics Medical

Mimics InPrint

Mimics Enlight

Formlabs FORM 3/3B/3BL

Stratasys J5 MEDIJET, J750/ J735/J850, OBJET30 PRIME

HP MJF 580

Ultimaker S5

Yes

✓

✓

✓

   

< 0.2 mm

[14, 17]

Synopsys

Simpleware ScanIP Medical

Formlabs FORM 3B/3BL

Stratasys J5 MEDIJET, J750/J850

HP MJF 580

Rize XRIZE

Yes

✓

✓

✓

   

Not reported

[18]

3D Systems

D2P

3D Systems ProJet CKP 660Pro

3D Systems ProJet 7000 HD

3D Systems ProJet MJP 5600

3D Systems ProX SLS 6100

Yes

✓

✓

✓

✓

✓

✓

Not reported

[19, 20]

Ricoh

Ricoh 3D Anatomic Models

Stratasys J5 MEDIJET, J750, F370

Yes

✓

✓

    

Not reported

[21, 22]

Axial 3D

Axial3D Cloud Segmentation Service

Formlabs FORM 3B

Stratasys J5 MEDIJET, J750/J735

HP MJF 580, 540

Yes

✓

✓

✓

   

Not reported

[23, 24]

Coreline Software Company

AVIEW Modeler

Stratasys Objet260 Connex3

No

      

Not reported

[15]

Medviso

Segment 3DPrint

Formlabs FORM 3B+

Formlabs Fuse 1

Yes

✓

✓

✓

   

< 1 mm

[25, 26]