# Tomey Corporation USA

- Location (FDA's records): Cambridge, MA
- FDA decisions: 10 (1991–2002): 10 510(k) clearances
- Names in FDA's records: Tomey Corporation USA (9); Tomey Corp. USA (1)
- Product codes: HJO (2), HKY (1), IYO (1), HLT (1), HKO (1), LQJ (1), HLZ (1), GWE (1), HKI (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 7 (2 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
- Tandem Scanning Corp.: 1 (https://510kreport.com/company/tandem-scanning)
- Biophysic Medical, Inc.: 1 (https://510kreport.com/company/biophysic-medical)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Zeiss Humphrey System: 1 (https://510kreport.com/company/zeiss-humphrey-system)
- Paradigm Medical Industries, Inc.: 1 (https://510kreport.com/company/paradigm-medical-industries)
- Sauquoit Industries, Inc.: 1 (https://510kreport.com/company/sauquoit-industries)
- Cadwell Laboratories, Inc.: 1 (https://510kreport.com/company/cadwell-laboratories)
- Life-Tech Intl., Inc.: 1 (https://510kreport.com/company/life-tech-intl)

## Firms that cite its devices most
- Electro-Diagnostic Imaging, Inc.: 1 (https://510kreport.com/company/electro-diagnostic-imaging)
- Eye Tel Imaging, Inc.: 1 (https://510kreport.com/company/eye-tel-imaging)
- Mrp Group, Inc.: 1 (https://510kreport.com/company/mrp-group)
- Zeta Development Laboratories: 1 (https://510kreport.com/company/zeta-development-laboratories)
- Nidek Technologies Srl: 1 (https://510kreport.com/company/nidek-technologies)

## Its most-cited devices
- K971685: Imagescape Digital Retinal Image System (1997), cited by 3
- K971953: Confoscan (1997), cited by 1
- K944910: Tomey EM-1000 Specular  Microscope (1994), cited by 1
- K945959: Video Vision Analyzer (Viva), VRB 100 (1995), cited by 1
- K932571: Tomey PE-400 Portable Erg & Vep with Optional PS-4 (1995), cited by 1

## Recent decisions
- K020151: UD-1000 Ultrasonic a/B Scanner (Apr 10, 2002)
- K971953: Confoscan (Aug 14, 1997)
- K971685: Imagescape Digital Retinal Image System (Jun 24, 1997)
- K961805: Tomey DTL Electrode (May 9, 1997)
- K932571: Tomey PE-400 Portable Erg & Vep with Optional PS-4 (Aug 31, 1995)
- K945959: Video Vision Analyzer (Viva), VRB 100 (Mar 1, 1995)
- K944910: Tomey EM-1000 Specular  Microscope (Nov 22, 1994)
- K924760: Tomey Proton Tonometer (Apr 5, 1993)

Source page: https://510kreport.com/company/tomey-usa