Identity
- Trade Name
- Surface Applicator Cone, 10 mm FDA UDI
- Generic Name
- Intraoperative/postoperative therapeutic x-ray system surface applicator FDA UDI
- Device Name
- Surface Applicator Cone, 10mm FDA UDI
- Model / Reference
- 711107 FDA UDI
- Description
- Surface Applicator Cone, 10mm FDA UDI
Identifiers
- Catalog Number
- SK1010 FDA UDI
- Primary DI / UDI-DI
- 00858012005618 FDA UDI
- 510(k) Number
- K083734 FDA UDI
- FDA Product Code
- JAD FDA UDI
- GMDN Term
- Intraoperative/postoperative therapeutic x-ray system surface applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5900 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
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoperative/postoperative therapeutic x-ray system surface applicator
Surface Applicator Cone, 10 mm by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative/postoperative therapeutic x-ray system surface applicator.
- INTRABEAM® Surface Applicator Set 3.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Surface Applicator Set 1.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Surface Applicator Set 4.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Surface Applicator Set 2.0 cm — Carl Zeiss Meditec AG · Class II
- Surface Applicator Set — Icad, Inc. · Class II
- (10) Applicator End Cap, 50 mm — Icad, Inc. · Class II
- (10) Applicator End Cap, 35 mm — Icad, Inc. · Class II
- Surface Applicator Cone, 35 mm — Icad, Inc. · Class II
Cleared under the same submission
K083734 also covers:
- (10) Applicator End Cap, 10 mm — Icad, Inc.
- (10) Applicator End Cap, 20 mm — Icad, Inc.
- (10) Applicator End Cap, 35 mm — Icad, Inc.
- (10) Applicator End Cap, 50 mm — Icad, Inc.
- Surface Applicator Cone, 20 mm — Icad, Inc.
- Surface Applicator Cone, 35 mm — Icad, Inc.
- Surface Applicator Cone, 50 mm — Icad, Inc.
- Surface Applicator Set — Icad, Inc.
- Surface Applicator Set Bundle 1 — Icad, Inc.
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
- Icad, Inc.
Sources (1)
- FDA UDI 313138df-fe64-4d42-9b82-42ee889bac4b 35 fields · synced Jun 8, 2026