HealthCXR
FDA 510(k) K192320 · Zebra Medical Vision, Ltd.
510(k) numberK192320
Submission
- Device name
- HealthCXR
- Applicant
- Zebra Medical Vision, Ltd.
Sefayim, IL - Received
- August 26, 2019
- Decision date
- November 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFM – Radiological Computer-Assisted Prioritization Software For Lesions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
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Questions and answers
When was HealthCXR cleared by the FDA?
HealthCXR (K192320) received a 510(k) decision of Substantially Equivalent on November 26, 2019, 92 days after the submission was received.
What is the product code of K192320?
The FDA product code is QFM – Radiological Computer-Assisted Prioritization Software For Lesions, a Class II (moderate risk) device regulated under 21 CFR 892.2080.