# Nucletron Corp.

- Location (FDA's records): Columbia, MD
- FDA decisions: 61 (1995–2026): 61 510(k) clearances
- Names in FDA's records: Nucletron Corp. (27); Nucletron Corporation (19); Nucletron B.V. (12); Nucletron (3)
- Product codes: JAQ (35), MUJ (13), KPQ (5), IYE (4), JAD (2), KXK (1), KPR (1)
- 510(k) review time since 2016: median 221 days, against 91 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 68 (27 its own); citations of its devices by later devices: 68 (27 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nucletron-Oldelft Corp.: 22 (https://510kreport.com/company/nucletron-oldelft)
- Oldelft Corp. of America: 3 (https://510kreport.com/company/oldelft-of-america)
- General Electric Co.: 2 (https://510kreport.com/company/general-electric)
- Icad, Inc.: 1 (https://510kreport.com/company/icad)
- Topex, Inc.: 1 (https://510kreport.com/company/topex)
- Life Imaging Systems, Inc.: 1 (https://510kreport.com/company/life-imaging-systems)
- Imacom, Inc.: 1 (https://510kreport.com/company/imacom)
- Mds Nordion: 1 (https://510kreport.com/company/mds-nordion)

## Firms that cite its devices most
- Isodose Control B.V.: 5 (https://510kreport.com/company/isodose-control)
- Amertek Medical, Inc.: 3 (https://510kreport.com/company/amertek-medical)
- Computerized Medical Systems, Inc.: 3 (https://510kreport.com/company/computerized-medical-systems)
- Proxima Therapeutics, Inc.: 3 (https://510kreport.com/company/proxima-therapeutics)
- Varian Medical Systems, Inc.: 3 (https://510kreport.com/company/varian-medical-systems)
- Alpha-Omega Services, Inc.: 2 (https://510kreport.com/company/alpha-omega-services)
- Elekta Inc. D/B/A Nucletron Corporation: 2 (https://510kreport.com/company/elekta-d-b-a-nucletron)
- Biolucent, Inc.: 2 (https://510kreport.com/company/biolucent)

## Its most-cited devices
- K983343: Plato Brachytheraphy, Model V. 14.0 (1999), cited by 6
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy) (2008), cited by 5
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE (1999), cited by 5
- K032372: Nucletron Comfort Catheter System, Model 189.007 (2003), cited by 4
- K003270: Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 (2000), cited by 4
- K073107: Valencia Skin Applicator Set, Model: 189.701 (2007), cited by 3

## Recent decisions
- K262383: LumenCare Azure (Jul 24, 2026)
- K251037: Rectal Applicator (Dec 19, 2025)
- K213942: Esteya (Jan 11, 2022)
- K201272: Geneva (Jul 16, 2020)
- K161688: Advanced Gynecological Applicator (Jan 27, 2017)
- K151272: Henschke Titanium Applicator Set (Jun 23, 2015)
- K142439: Martinez Prostate Template Set (Mar 10, 2015)
- K140803: Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM (Jun 26, 2014)

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