Identity
- Trade Name
- EXSYS DEXi FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Model / Reference
- EXSYS DEXi-D401S-FRM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018421505 FDA UDI
- 510(k) Number
- K242847 FDA UDI
- FDA Product Code
- KPR FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
EXSYS DEXi by Drtech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, digital.
- DX-D 400 — Agfa Corp. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- iDR603V-110 — YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. · Class IIb
- RADspeed fit — Shimadzu Corp. · Class II
Cleared under the same submission
K242847 also covers:
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
- EXSYS DEXi — Drtech Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drtech Corp.
Sources (1)
- FDA UDI 789afe3f-a240-4894-810f-11f4cacfd879 33 fields · synced Jun 6, 2026