SEDECAL ChallengeX AP
GUDID 08436046002388
The CHALLENGEX AP Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Stationary basic diagnostic x-ray system, analogue| Primary Device ID | 08436046002388 |
| NIH Device Record Key | 4beeaf8a-76a8-4265-a902-87fad1998426 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEDECAL |
| Version Model Number | Radiographic System Challenge X |
| Catalog Number | ChallengeX AP |
| Company DUNS | 510948979 |
| Company Name | SEDECAL |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Serial Number | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08436046002388 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202293
FDA Product Code
| KPR | System, X-Ray, Stationary |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-30 |
| Device Publish Date | 2020-11-20 |
On-Brand Devices [SEDECAL]
| 08436046002364 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002494 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002487 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002470 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002463 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002456 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002449 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002432 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002609 | This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec |
| 08436046002593 | This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec |
| 08436046002586 | This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec |
| 08436046002579 | This mobile digital radiographic system is intended for use by a qualified/trained doctor or tec |
| 08436046002517 | The SEDECAL X PLUS LP PLUS Radiographic Systems with (or without) Digital Detector are intended |
| 08436046002500 | The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or techn |
| 08436046002562 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002555 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002548 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002531 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002388 | The CHALLENGEX AP Radiographic System is intended for use by a qualified/trained doctor or tech |
| 08436046003033 | The Proteus XR/f ET Radiographic Systems with (or without) Digital Detector are intended for use |
| 08436046003026 | The Proteus XR/f ST Radiographic Systems with (or without) Digital Detector are intended for use |
| 08436046002937 | Stationary diagnostic x-ray table |
| 08436046002241 | Floor mounted radiological tube stand |
| 08436046001954 | Ceiling Mount X-ray tube stand |
| 08436046001947 | Ceiling Mount X-ray tube stand |
| 08436046001930 | Ceiling Mount X-ray tube stand |
| 08436046000995 | Floor mounted diagnostic x-ray tube stand |
| 08436046000988 | Floor mounted diagnostic x-ray tube stand |
| 08436046003019 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003002 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002999 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002982 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002975 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002968 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002951 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046002944 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046001879 | This is a portable digital diagnostic x-ray system Intended for use by a qualified/trained docto |
| 08436046003170 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003163 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003156 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003149 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003132 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003125 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003118 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003101 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003293 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003286 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003279 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003262 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
| 08436046003095 | Intended for use by a qualified/trained doctor or technician on both adult and pediatric subject |
Trademark Results [SEDECAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEDECAL 74630773 not registered Dead/Abandoned |
SEDECAL, S.A. 1995-02-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.