| Primary Device ID | 00850019946543 |
| NIH Device Record Key | 654ffbfb-c38b-49a5-bf99-2e504979c18d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Imaging IMSure 3D |
| Version Model Number | 91365 |
| Catalog Number | 91365 |
| Company DUNS | 788084705 |
| Company Name | STANDARD IMAGING INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019946543 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-07 |
| Device Publish Date | 2023-11-29 |
| 00850019946543 - Standard Imaging IMSure 3D | 2023-12-07Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy. |
| 00850019946543 - Standard Imaging IMSure 3D | 2023-12-07 Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan |
| 00850019946031 - Standard Imaging Seed Slider | 2023-06-30 Standard Imaging Seed Slider is designed for loading LDR Brachytherapy seeds and spacers into prostate needles. |
| 00850019946048 - Standard Imaging Needle Loading Shield | 2023-06-30 Standard Imaging Needle Loading Shield provide a convenient work station for counting and handling seeds and for loading into n |
| 00850019946062 - Standard Imaging Needle Cradle | 2023-06-30 Standard Imaging Needle Cradle is designed for storage of loaded LDR prostate implant needles, prior to use in a patient. |
| 00850019946079 - Standard Imaging CDX 2000B Electrometer | 2023-06-30 Standard Imaging CDX 2000B Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization |
| 00850019946086 - Standard Imaging MAX 4000 Plus Electrometer | 2023-06-30 Standard Imaging MAX 4000 Plus Electrometer is a portable electrometer designed to be connected to a radiation detector, (ioniza |
| 00850019946093 - Standard Imaging SuperMAX Electrometer | 2023-06-30 Standard Imaging SuperMAX Electrometer is a 2-channel electrometer designed to be connected to a radiation detector, (ionization |
| 00850019946109 - Standard Imaging MAX SD | 2023-06-30 Standard Imaging MAX SD is a high end optical signal processing electrometer designed for use with Exradin W2 scintillation dete |