Identifiers
- 510(k) Number
- K954161 FDA 510(k)
- FDA Product Code
- EAM FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1960 FDA 510(k)
- Regulation Number
- 892.1960 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Jpi Intensifying Screen by Jpi Healthcare. Co., Ltd. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954161 | Class I | Active |
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Manufacturer
- Manufacturer
- Jpi Healthcare. Co., Ltd.
- FDA Applicant
- Jpi Healthcare Co, Ltd.
Sources (1)
- FDA 510(k) K954161 24 fields · synced Jun 19, 2026