FDA.reportPublic FDA data

Micro C Medical Imaging System, M01

Primary DI
00860001123401
Brand
Micro C Medical Imaging System, M01
Company
OXOS Medical, Inc.
Model
M01
Published
2021-03-08
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203658000Micro C Medical Imaging System, M01Oxos Medical, Inc.2021-01-12IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001123401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001123401008600011234018600011234010860001123401

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose hand-held diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture and display and manipulation. It typically operates on battery power and is designed to be easily carried from location to location by a single operator. It is most commonly used in sports medicine or military applications. It consists of a modular configuration that can be upgraded by the addition of hardware or software components and/or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius33 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 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
00850079606043MC2 Portable X-ray SystemMC2.12026-03-25
00850079606050EmitterE1.12026-03-25
00860001123418CassetteC12025-01-01
00860001123425EmitterE12025-01-01
00860008892706Foot PedalF12025-01-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21