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Companies / OXOS Medical
Medical device company profile

OXOS Medical

Atlanta-based manufacturer of portable X-ray systems for point-of-care orthopedic imaging.

Manufacturer / DeveloperDiagnostics & ImagingOrthopedics & MusculoskeletalDiagnostic ImagingCommercial-stage
HeadquartersπŸ‡ΊπŸ‡ΈAtlanta, Georgia, United States
Founded2016
Commercial statusCommercially availableU.S. availability reported by manufacturer; specified-unit recall recorded
Employees51–200 [25]LinkedIn company-size range Β· Checked 2026-10-15
Estimated revenueNot confirmed
Disclosed fundingUS$45 million [23]Company-reported total Β· Apr 2023
Official websiteoxos.com β†—

Company overview

OXOS Medical develops portable X-ray equipment. The company traces its founding to 2016 as Micro C, LLC.; its current MC2 system follows the earlier Micro C.

MC2 is offered in Clinic, LE, Go and Lab configurations. The company reports U.S. availability and provides direct sales contact options; these statements do not establish customer numbers or deployment scale.

Intel Capital announced a $23 million Series A co-led with Parkway Venture Capital in April 2023, reporting $45 million raised at that time. Those historical figures do not establish current financing or financial health.

[14][15][17][23][24]

Leadership

2 people
Evan M. RuffCEO and Co-founder [15]
Gregory P. Kolovich, MDChief Medical Officer and Co-founder [15]

Products & regulatory status How does MedTechIndex get this information?

Summary

MC2 has FDA 510(k) decisions K241567 and K252068 and is commercially available in the United States. The later labeling includes specified adult and pediatric imaging and excludes surgery and home/residential use. Earlier Micro C decisions are recorded as a separate platform lineage. [5][6][18][17][14][1]

The matched FDA history contains 1 distinct recall event: 1 open, 0 terminated. Z-2857-2026 (2026-06-11; open, classified): Due to a defective circuit board that overheats [11]

Regulatory snapshot How to read this snapshot

U.S. FDA
2
510(k) clearances
0
De Novo grants
0
PMA approvals
1
Recall events

Latest recorded source review: 2026-10-20.

Scope: selected product families.

View 1 documented open recall event
Documented open FDA recall events
Recalled product / recordInitiatedSource
  • MC2 Portable X-Ray SystemZ-2857-2026
June 11, 2026[11][22]

Commercial portfolio snapshot

One product family, offered in several configurations.

OXOS MC2 portable X-ray system
Image: OXOS Medical
Portable imaging

MC2 Portable X-ray System β†—

Portable X-ray platform for point-of-care orthopedic imaging. Clinic, LE, Go and Lab configurations offer different combinations of imaging modes and accessories; permitted clinical uses depend on the configuration and FDA labeling.

FDA-cleared Β· U.S.

Commercial development

In March 2026, OXOS announced pediatric imaging availability for MC2. This is an expansion of the marketed platform, rather than evidence of a separate pending application or a future launch date. [16]

Activity & Milestones

6 events
2026-06-11 Β· Recall

Specified-unit MC2 recall initiated

FDA records a firm-initiated recall, Z-2857-2026. The FDA posting followed on August 3, 2026; affected scope and current status are in the regulatory entry. [22]

2026-03-17 Β· Product announcement

Pediatric imaging announcement

OXOS announced pediatric imaging availability for MC2. This is a company announcement date, separate from the FDA decision date. [16]

2025-12-22 Β· Regulatory

Later MC2 FDA clearance

FDA recorded a second MC2 substantial equivalence determination, K252068. [21]

2024-12-06 Β· Regulatory

Original MC2 FDA clearance

FDA recorded a substantial equivalence determination under K241567. [20]

2023-04-05 Β· Funding

$23 million Series A announced

Intel Capital reported a round co-led with Parkway Venture Capital. The announcement put cumulative funding at $45 million at that time. [24]

2016 Β· Company formation

Company founded

OXOS reports that its predecessor, Micro C, LLC., was founded in 2016. [15]

25 Cited Sources

Accessed 10/29/2026

[1] FDA 510(k) database β€” research search β†—FDA / openFDA Β· regulatory record
[2] FDA K203658 β€” Micro C Medical Imaging System, M01 β†—U.S. Food and Drug Administration Β· regulatory record
[3] FDA K211473 β€” Micro C Medical Imaging System, M01 β†—U.S. Food and Drug Administration Β· regulatory record
[4] FDA K212654 β€” Micro C Medical Imaging System, M01 β†—U.S. Food and Drug Administration Β· regulatory record
[5] FDA K241567 β€” MC2 Portable X-ray System β†—U.S. Food and Drug Administration Β· regulatory record
[6] FDA K252068 β€” MC2 Portable X-ray System β†—U.S. Food and Drug Administration Β· regulatory record
[7] FDA De Novo database β€” research search β†—FDA / openFDA Β· regulatory record
[9] FDA PMA database β€” research search β†—U.S. Food and Drug Administration Β· regulatory database
[10] FDA PMA database β€” research search β†—FDA / openFDA Β· regulatory record
[11] FDA recall Z-2857-2026 β€” Oxos Medical Inc β†—U.S. Food and Drug Administration Β· regulatory record
[13] FDA UDI database β€” research search β†—FDA / openFDA Β· regulatory record
[15] OXOS company history and founders β†—OXOS Medical Β· company website
[16] OXOS announces pediatric MC2 imaging β†—OXOS Medical Β· company announcement Β· Published 2026-03-17
[17] MC2 configurations β†—OXOS Medical Β· company website
[18] K252068 clearance letter and indications for use β†—U.S. Food and Drug Administration Β· regulatory document
[19] FDA De Novo database β€” scoped no-match search, October 14, 2026 β†—U.S. Food and Drug Administration Β· regulatory database
[20] FDA 510(k): K241567 β†—U.S. Food and Drug Administration Β· regulatory database
[21] FDA 510(k): K252068 β†—U.S. Food and Drug Administration Β· regulatory database
[22] FDA recall: Z-2857-2026 β†—U.S. Food and Drug Administration Β· regulatory database
[24] OXOS $23 million Series A announcement β†—Intel Capital Β· investor announcement Β· Published 2023-04-05
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