Identity
- Trade Name
- HS AMICA FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- AMICA-GEN MW GENERATOR 140W FDA UDI
- Model / Reference
- AMICA-GEN FDA UDI
- Description
- AMICA-GEN MW GENERATOR 140W FDA UDI
Identifiers
- Catalog Number
- AGN-3.1 FDA UDI
- Primary DI / UDI-DI
- 08058983742068 FDA UDI
- 510(k) Number
- K150112 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Microwave hyperthermia system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 10.5 Kilogram FDA UDIDepth — 35 Centimeter FDA UDIWidth — 47 Centimeter FDA UDIHeight — 13 Centimeter FDA UDI
Category: Microwave hyperthermia system
Hs Amica by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave hyperthermia system.
- BSD-500 Hyperthermia System — Pyrexar Medical, Inc. · Class III
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- Emprint HP — Covidien LP · Class II
- Emprint — Covidien LP · Class II
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- Solero — ANGIODYNAMICS, INC · Class II
- Emprint — Covidien LP · Class II
- Evident — Covidien LP · Class II
Cleared under the same submission
K150112 also covers:
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- H.s. Hospital Service Spa
Sources (1)
- FDA UDI 51db7ada-80ee-448e-8ec7-cd7ab393f7bb 37 fields · synced Jun 8, 2026