# Imagyn Medical Technologies, Inc.

- Location (FDA's records): Laguna Niguel, CA
- FDA decisions: 7 (1998–2003): 7 510(k) clearances
- Product codes: LKY (2), DQA (1), IWJ (1), KXK (1), HCY (1), DSB (1)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Osbon Medical Systems, Ltd.: 2 (https://510kreport.com/company/osbon-medical-systems)
- International Isotopes, Inc.: 1 (https://510kreport.com/company/international-isotopes)
- Endo Technic Corp.: 1 (https://510kreport.com/company/endo-technic)
- Medi-Physics Inc. Dba Nycomed Amersham Imaging: 1 (https://510kreport.com/company/medi-physics-dba-nycomed-amersham-imaging)
- Ml Strategies, Inc.: 1 (https://510kreport.com/company/ml-strategies)
- Imagyn Medical, Inc.: 1 (https://510kreport.com/company/imagyn-medical)
- Milex Products, Inc.: 1 (https://510kreport.com/company/milex-products)

## Firms that cite its devices most
- Vacurect Manufacturing (Pty), Ltd.: 2 (https://510kreport.com/company/vacurect-manufacturing)
- Conmed Corporation: 2 (https://510kreport.com/company/conmed)
- Nuvasive, Inc.: 1 (https://510kreport.com/company/nuvasive)
- Repro-Med Systems, Inc.: 1 (https://510kreport.com/company/repro-med-systems)

## Its most-cited devices
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor (2003), cited by 2
- K980291: Impower External Vacuum System (1998), cited by 2
- K012706: IM2001 Pulse Oximeter (2003), cited by 1
- K974173: Erecaid System/Stay Erec System (1998), cited by 1

## Recent decisions
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor (Sep 4, 2003)
- K012706: IM2001 Pulse Oximeter (Mar 7, 2003)
- K010166: Imagyn Isosleeve / Isostar Needle System (Dec 3, 2001)
- K991526: Isostar I-125 Interstitial Seed, Model IS-12501 (Jun 17, 1999)
- K980096: Oac (Optical Aspirating Curette) (May 1, 1998)
- K980291: Impower External Vacuum System (Mar 11, 1998)
- K974173: Erecaid System/Stay Erec System (Feb 25, 1998)

Source page: https://510kreport.com/company/imagyn-medical-technologies