# Heartlab, Inc.

- Location (FDA's records): Westerly, RI
- FDA decisions: 6 (1995–2005): 6 510(k) clearances
- Product codes: LLZ (4), LMD (1), DPS (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems, Inc.: 3 (https://510kreport.com/company/philips-medical-systems)
- Agfa Corp.: 2 (https://510kreport.com/company/agfa)
- Camtronics, Ltd.: 1 (https://510kreport.com/company/camtronics)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Burdick Corp.: 1 (https://510kreport.com/company/burdick)
- Quinton, Inc.: 1 (https://510kreport.com/company/quinton)

## Firms that cite its devices most
- Medcon, Ltd.: 1 (https://510kreport.com/company/medcon)
- Thinking Systems Corp.: 1 (https://510kreport.com/company/thinking-systems)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Heartware, Inc.: 1 (https://510kreport.com/company/heartware)
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-biocare-bio-medical-equipment)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K050228: Agfa Heartlab Cardiovascular (2005), cited by 2
- K050858: Ascentia Heartstation Ecg Management System (2005), cited by 2
- K954479: Dicomview (1996), cited by 1
- K040896: Modification to Encompass (2004), cited by 1
- K954860: Echonet (1995), cited by 1

## Recent decisions
- K050858: Ascentia Heartstation Ecg Management System (Jun 29, 2005)
- K050228: Agfa Heartlab Cardiovascular (Feb 18, 2005)
- K042042: Ultrasound Capture System (Sep 21, 2004)
- K040896: Modification to Encompass (Jul 16, 2004)
- K954479: Dicomview (Feb 21, 1996)
- K954860: Echonet (Dec 21, 1995)

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