Data / Medical devices / Endoscope, Accessories, Image Post-Processing For Color Enhancement
Endoscope, Accessories, Image Post-Processing For Color Enhancement (PEA): 9 FDA-registered makers in 2 countries
9 establishments in 2 countries are registered with the FDA to make Endoscope, Accessories, Image Post-Processing For Color Enhancement (product code PEA, Class 2, 21 CFR 876.1500). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on June 3, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PEA
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Japan | 8 |
| Malaysia | 1 |
Makers of Endoscope, Accessories, Image Post-Processing For Color Enhancement
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 6 | June 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 6 | June 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn.Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yoshikawa Kasei Co., Ltd. Medical Company Osaka Plant | Osaka-shi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yoshikawa Kasei Co., Ltd. Medical Company Shizuoka Plant | Fukuroi City Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.