Identity
- Trade Name
- Standard Imaging Lucy 3D QA Phantom FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, test object FDA UDI
- Device Name
- Standard Imaging Lucy 3D QA Phantom is designed to perform comprehensive quality assurance tests for an entire stereotactic radiosurgery/SRT procedure. The phantom allows verification of treatment planning software calculations for volume measurements, distance measurements, image fusion and image transfer. Dosimetry verification is accomplished via components that accommodate ion chambers, film, MOSFETs, TLDs and polymer gels. FDA UDI
- Model / Reference
- 91210 FDA UDI
- Description
- Standard Imaging Lucy 3D QA Phantom is designed to perform comprehensive quality assurance tests for an entire stereotactic radiosurgery/SRT procedure. The phantom allows verification of treatment planning software calculations for volume measurements, distance measurements, image fusion and image transfer. Dosimetry verification is accomplished via components that accommodate ion chambers, film, MOSFETs, TLDs and polymer gels. FDA UDI
Identifiers
- Catalog Number
- 91210 FDA UDI
- Primary DI / UDI-DI
- 00850019946505 FDA UDI
- FDA Product Code
- IXG FDA UDI
- GMDN Term
- Multi-modality therapeutic radiation phantom, test object FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1950 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality therapeutic radiation phantom, test object
Standard Imaging Lucy 3D QA Phantom by Standard Imaging, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality therapeutic radiation phantom, test object.
- QUASAR — Modus Medical Devices Inc · Class I
- THALES 3D MR SCANNER — L A P GMBH LASER APPLIKATIONEN · Class II
- QUASAR — Modus Medical Devices Inc · Class I
- Couchtop Base Varian Exact — 3C-Medical Intelligence GmbH · Class I
- Cranial 4Pi Wedge 5 Deg. — Brainlab SE · Class I
- Calibration Cube and Levelling Plate — Vision RT Ltd. · Class I
- QUASAR — Modus Medical Devices Inc · Class I
- QUASAR — Modus Medical Devices Inc · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (1)
- FDA UDI fa496635-8537-4d66-b977-73068d890f0b 34 fields · synced May 30, 2026