# Superdimension, Ltd.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 12 (2004–2012): 12 510(k) clearances
- Names in FDA's records: Superdimension, Ltd. (10); Superdimension, Inc. (2)
- Product codes: JAK (10), EOQ (1), LLZ (1)
- Predicates its devices cite: 19 (13 its own); citations of its devices by later devices: 25 (13 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Radiomed Corporation: 1 (https://510kreport.com/company/radiomed)
- Cortex Manufacturing, Inc.: 1 (https://510kreport.com/company/cortex-manufacturing)
- Somatex Medical Technologies GmbH: 1 (https://510kreport.com/company/somatex-medical-technologies)
- Ultraguide, Ltd.: 1 (https://510kreport.com/company/ultraguide)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Olympus Optical Co., Ltd.: 1 (https://510kreport.com/company/olympus-optical)

## Firms that cite its devices most
- Broncus Technologies, Inc.: 3 (https://510kreport.com/company/broncus-technologies)
- Mauna Kea Technologies: 2 (https://510kreport.com/company/mauna-kea-technologies)
- Veran Medical Technologies, Inc.: 2 (https://510kreport.com/company/veran-medical-technologies)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Paieon, Inc.: 1 (https://510kreport.com/company/paieon)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Kgt, Inc.: 1 (https://510kreport.com/company/kgt)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Its most-cited devices
- K081379: Modification to Inreach System (2008), cited by 5
- K042438: Superdimension/Bronchus (2004), cited by 5
- K071473: Modification to Superdimension/Bronchus Premium 2 (2007), cited by 3
- K080271: Inreach System (2008), cited by 3
- K102604: I-Logic Inreach System (2010), cited by 2
- K092365: Inreach System, Model AAS00161-02 (2009), cited by 2

## Recent decisions
- K120796: Superdimension Nitinol/Gold Fiducial Marker (Oct 26, 2012)
- K110093: Superdimension Marker Delivery Kit (Feb 11, 2011)
- K102604: I-Logic Inreach System (Oct 7, 2010)
- K092365: Inreach System, Model AAS00161-02 (Sep 4, 2009)
- K082386: Inreach Planning Laptop (Sep 16, 2008)
- K081379: Modification to Inreach System (Jun 11, 2008)
- K080271: Inreach System (Mar 31, 2008)
- K071473: Modification to Superdimension/Bronchus Premium 2 (Jul 12, 2007)

Source page: https://510kreport.com/company/superdimension