# Sectra-Imtec AB

- Location (FDA's records): Denton, TX
- FDA decisions: 14 (1996–2011): 14 510(k) clearances
- Names in FDA's records: Sectra-Imtec AB (9); Sectra Imtec AB (5)
- Product codes: LLZ (9), LMB (2), LMD (1), KGI (1), MUE (1)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 34 (6 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pronosco A/S: 1 (https://510kreport.com/company/pronosco-a-s)
- Olicon Imaging Systems, Inc.: 1 (https://510kreport.com/company/olicon-imaging-systems)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Fujifilm Medical System U.S.A., Inc.: 1 (https://510kreport.com/company/fujifilm-medical-system-usa)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- O Tech, Inc.: 1 (https://510kreport.com/company/o-tech)

## Firms that cite its devices most
- Confirma, Inc.: 2 (https://510kreport.com/company/confirma)
- Hologic, Inc.: 2 (https://510kreport.com/company/hologic)
- Dr Systems, Inc.: 2 (https://510kreport.com/company/dr-systems)
- O Tech, Inc.: 2 (https://510kreport.com/company/o-tech)
- American Medical Sales, Inc.: 2 (https://510kreport.com/company/american-medical-sales)
- Philips Digital Mammography Sweden AB: 2 (https://510kreport.com/company/philips-digital-mammography-sweden)
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Realtimeimage, Inc.: 1 (https://510kreport.com/company/realtimeimage)

## Its most-cited devices
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package (2004), cited by 7
- K031590: Sectra Orthopedic Package (2003), cited by 5
- K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1 (2003), cited by 5
- K002936: Modification to IDS5 Image Display System (2000), cited by 4
- K063093: Sectra Workstation, Version 11.1 (2006), cited by 3
- K050196: Sectra IDS5 Workstation (2005), cited by 3

## Recent decisions
- K110025: Sectra Microdose Mammography (Apr 28, 2011)
- K081469: Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2 (Jun 12, 2008)
- K063093: Sectra Workstation, Version 11.1 (Nov 7, 2006)
- K051315: Modification to: Sectra IDS5 Workstation (Jun 15, 2005)
- K050196: Sectra IDS5 Workstation (Feb 24, 2005)
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package (May 4, 2004)
- K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1 (Dec 23, 2003)
- K031590: Sectra Orthopedic Package (Oct 2, 2003)

Source page: https://510kreport.com/company/sectra-imtec