# Elscint, Inc.

- Location (FDA's records): Hackensack, NJ
- FDA decisions: 94 (1981–1998): 94 510(k) clearances
- Product codes: LNH (17), JAK (16), IZH (10), IYO (10), IYX (5), KPS (5), HGL (2), IYN (2), JOP (2), IZF (1), LNI (1), IZL (1)
- Predicates its devices cite: 32 (23 its own); citations of its devices by later devices: 37 (23 its own)
- Recalls linked to its devices: 14 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 3 (https://510kreport.com/company/ge-medical-systems)
- Elscint Mr, Inc.: 2 (https://510kreport.com/company/elscint-mr)
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Medical Advances, Inc.: 1 (https://510kreport.com/company/medical-advances)

## Firms that cite its devices most
- Ge Medical Systems F.I. Haifa: 4 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- Perception, Inc.: 3 (https://510kreport.com/company/perception)
- Philips Medical Systems (Cleveland), Inc.: 2 (https://510kreport.com/company/philips-medical-systems-cleveland)
- General Electric Co.: 1 (https://510kreport.com/company/general-electric)
- Marconi Medical Systems, Inc.: 1 (https://510kreport.com/company/marconi-medical-systems)
- Lodox Systems (Pty), Ltd.: 1 (https://510kreport.com/company/lodox-systems)
- Vital Images, Inc.: 1 (https://510kreport.com/company/vital-images)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Its most-cited devices
- K954039: Gyrex Privilege (1995), cited by 5
- K945791: Gyres 2T Prestige (1995), cited by 5
- K945512: HRSW Option for CT Twin Flash (1995), cited by 4
- K961464: Select/SP (1996), cited by 3
- K935024: ESI-5000 (1996), cited by 3
- K970980: Cardiac Scoring for CT Scanners (1997), cited by 2

## Recent decisions
- K983313: Advanced Automatic Detector Selection Option for Glory (Dec 11, 1998)
- K982060: Volumax CT Imaging System (Sep 2, 1998)
- K974344: CT Scope (Jun 3, 1998)
- K980306: Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EP (Apr 2, 1998)
- K974614: Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102 (Mar 4, 1998)
- K972592: 2T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101) (Sep 15, 1997)
- K970680: GLORY (Jun 20, 1997)
- K965044: Gyrex 2T Prestige Model NO. 100-6321-0107 and Gyrex Privilege Model NO. 100-6326-0102 (Jun 16, 1997)

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