FDA.reportPublic FDA data

Foot Pedal

Primary DI
00860008892706
Brand
Foot Pedal
Company
OXOS Medical, Inc.
Model
F1
Published
2025-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile
OWBInterventional Fluoroscopic X-Ray System
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241567000MC2 Portable X-ray SystemOxos Medical2024-12-06OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008892706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008892706008600088927068600088927060860008892706

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius29.9 Degrees Celsius
Special Storage Condition, Specify00Altitude: Between 1000 ft below sea level and 8,000 ft above sea level
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080323883
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850079606081MC2 Portable X-ray SystemMC2.22026-09-21
00850079606098EmitterE1.22026-09-21
00850079606104CassetteC1.12026-09-21
00850079606043MC2 Portable X-ray SystemMC2.12026-03-25
00850079606050EmitterE1.12026-03-25
00860001123418CassetteC12025-01-01
00860001123425EmitterE12025-01-01
00860008892713Wired ChargerH12025-01-01
00860008892737CartK12025-01-01
00860008892744MC2 AppAPP2025-01-01
00860008892782MC2 Portable X-ray SystemMC22025-01-01
00860008892768Foot and Ankle StandG12025-06-02
00860008892751Micro C Load Bearing Cassette Plate, ACSY-S009ACSY-S0092022-10-19
00860001123470OXBoxACSY-S0212022-07-01
00860001123456Micro C Medical Imaging System, Point of Care Cart Cassette HolderACSY-S0142022-06-13
00860001123463Micro C Medical Imaging System, Emitter TripodACSY-S0152022-06-13
00860001123487Micro C Medical Imaging System, Weight Bearing Foot and Ankle SystemACSY-S0162022-06-13
00860001123449Micro C Medical Imaging System, Point of Care Cart, M01ACSY-S0122022-04-13
00860001123432Micro C Medical Imaging System, M01 Foot PedalACSY-P0362022-03-16
00860001123401Micro C Medical Imaging System, M01M012021-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014490156EUROPAAspen Imaging Healthcare IncIZL2026-10-16
00860016243804C-beamPulmera, Inc.OWB2026-10-10
00884838120433SmartCTPhilips Medical Systems Nederland B.V.OWB2026-09-28
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.IZL2026-09-21
00850079606098EmitterOXOS Medical, Inc.OXO2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.IZL2026-09-21
00850079606104CassetteOXOS Medical, Inc.OXO2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
00860014490163APX-24Aspen Imaging Healthcare IncIZL2026-09-08
00860015436306EUROPAAspen Imaging Healthcare IncIZL2026-09-08
00860015436313EUROPAAspen Imaging Healthcare IncIZL2026-09-08
00860015436320EUROPAAspen Imaging Healthcare IncIZL2026-09-08
08800098700187XLITEGEMSS Healthcare Co., Ltd.IZL2026-08-26
G221500MC009H0iQ FlexFirst Source, Inc.IZL2026-08-25
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONOWB2026-08-14
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10