| Primary Device ID | 00812266030444 | 
| NIH Device Record Key | 64e06479-975d-4cad-9fa8-b950732a6019 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Catphan® | 
| Version Model Number | CTP515 | 
| Catalog Number | CTP515 | 
| Company DUNS | 104162493 | 
| Company Name | Providus Holdings, Inc. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00812266030444 [Primary] | 
| IXF | Test-Pattern, Radiographic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-10-31 | 
| Device Publish Date | 2023-10-23 | 
| 00812266030024 | Catphan® 500, Complete Catphan® including housing, case, and Smári Image Analysis Database Se | 
| 00812266030048 | Catphan® 700, Complete Catphan® including housing, case, and Smári Image Analysis Database Se | 
| 00812266030031 | Catphan® 600, Complete Catphan® including housing, case, and Smári Image Analysis Database Se | 
| 00812266030017 | COPDGene Lung Phantom ll | 
| 00812266030147 | 38cm OD 10cm thick uniformity material body annulus | 
| 00812266030130 | 38cm OD 5cm thick uniformity material body annulus | 
| 00812266030123 | 35cm OD 5cm thick uniformity material body annulus | 
| 00812266030116 | 32cm OD 20cm thick uniformity material body annulus | 
| 00812266030109 | 32cm OD 15cm thick uniformity material body annulus | 
| 00812266030093 | 32cm OD 10cm thick uniformity material body annulus | 
| 00812266030086 | 32cm OD 5cm thick uniformity material body annulus | 
| 00812266030079 | 30cm OD 5cm thick uniformity material body annulus | 
| 00812266030062 | Teflon annulus | 
| 00812266030444 | Subslice and supra-slice low contrast module | 
| 00812266030437 | Solid image uniformity module | 
| 00812266030420 | 21 line pair high resolution and point source module | 
| 00812266030413 | Slice width, sensitometry and pixel size module | 
| 00812266030406 | Catphan® 608, Complete Catphan® including housing and case | 
| 00812266030390 | Catphan® 606, Complete Catphan® for kVCT and MVCT including housing and case, | 
| 00812266030383 | Catphan® 605, Compact Catphan® including housing and case | 
| 00812266030376 | Catphan® 604, Complete Catphan® for Cone Beam CT including housing and case | 
| 00812266030369 | Catphan® 508, Complete Catphan® including housing and case. | 
| 00812266030352 | Catphan® 504,Complete Catphan® for Cone Beam CT including housing and case | 
| 00812266030345 | Catphan® 503, Complete Catphan® for Cone Beam CT including housing and case | 
| 00812266030338 | Catphan® 346, Catphan® for small diameter low contrast testing, including housing and case | 
| 00812266030321 | Catphan® 343, Catphan® for small diameter low contrast testing, including housing and and case | 
| 00812266030314 | Scatter block extention for Catphan® 700 (use with annuli) | 
| 00812266030307 | 45° High resolution block with uniformity holder and mount | 
| 00812266030291 | 45° High resolution block | 
| 00812266030284 | High Density Insert Set for Catphan® 700 | 
| 00812266030277 | Scatter extension for Catphan® 600 | 
| 00812266030260 | 42-55cm oval OD 20cm thick uniformity material body annulus | 
| 00812266030253 | 42-55cm oval OD 10cm thick uniformity material body annulus | 
| 00812266030246 | 30-38cm oval OD 20cm thick uniformity material body annulus | 
| 00812266030239 | 30-38cm oval OD 15cm thick uniformity material body annulus | 
| 00812266030222 | 30-38cm oval OD 10cm thick uniformity material body annulus | 
| 00812266030215 | 30-38cm oval OD 5cm thick uniformity material body annulus | 
| 00812266030208 | 25-35cm oval OD 20cm thick uniformity material body annulus | 
| 00812266030192 | 25-35cm oval OD 15cm thick uniformity material body annulus | 
| 00812266030185 | 25-35cm oval OD 10cm thick uniformity material body annulus | 
| 00812266030178 | 25-35cm oval OD 5cm thick uniformity material body annulus | 
| 00812266030161 | 38cm OD 20cm thick uniformity material body annulus | 
| 00812266030154 | 38cm OD 15cm thick uniformity material body annulus | 
| 00812266030512 | 16cm OD housing and mount | 
| 00812266030505 | Catphan® case | 
| 00812266030499 | Catphan® 600 mount assembly | 
| 00812266030482 | Catphan® 600 housing | 
| 00812266030475 | 30 line pair high resolution module | 
| 00812266030468 | Geometry sensitometry and point source module | 
| 00812266030451 | 40mm bead geometry module | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CATPHAN  73135816  1085938 Live/Registered | ALDERSON RESEARCH LABORATORIES, INC. 1977-07-29 |