Identity
- Trade Name
- IA-12LM13 FDA UDI
- Generic Name
- X-ray image intensifier FDA UDI
- Model / Reference
- 532-16883-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217046973 FDA UDI
- 510(k) Number
- K012424 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- X-ray image intensifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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: X-ray image intensifier
Ia-12lm13 by Shimadzu Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray image intensifier.
- IA-12LT/HS13 — Shimadzu Corp. · Class II
- IA-12LT13 — Shimadzu Corp. · Class II
- IA-16LD/HS13 — Shimadzu Corp. · Class II
- IA-12LT/HS — Shimadzu Corp. · Class II
- IA-12LD — Shimadzu Corp. · Class II
- IA-16LT/HS13 — Shimadzu Corp. · Class II
- IA-12LT/HS13 — Shimadzu Corp. · Class II
- IA-16LM(6)/HS12 — Shimadzu Corp. · Class II
Cleared under the same submission
K012424 also covers:
- IA-12LD — Shimadzu Corp.
- IA-12LD — Shimadzu Corp.
- IA-12LD/HS — Shimadzu Corp.
- IA-12LD/HS13 — Shimadzu Corp.
- IA-12LD/HS13 — Shimadzu Corp.
- IA-12LD13 — Shimadzu Corp.
- IA-12LD13 — Shimadzu Corp.
- IA-12LM — Shimadzu Corp.
- IA-12LM — Shimadzu Corp.
- IA-12LM — Shimadzu Corp.
- IA-12LM13 — Shimadzu Corp.
- IA-12LT — Shimadzu 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 |
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Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA UDI 53c4c8e8-f546-4193-bd32-1ff5cc43541c 33 fields · synced Jun 8, 2026