FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
HESTIA
K Number: K243420
·
Decision Jul 17, 2025
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
24
Review Days
255
Basic Information
- Device Name
- HESTIA
- K Number
- K243420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genoray Co., Ltd.
- Date Received
- November 4, 2024
- Decision Date
- July 17, 2025
- Product Code
- MUE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUE), ordered by most recent decision date.
MAMMOMAT B.brilliant (11372950)
FDA 510(k)
FDA Class 2
·Radiology
Bellalun 2D (VDMS-1000S)
FDA 510(k)
FDA Class 2
·Radiology
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k)
FDA Class 2
·Radiology
2430TCA with Xmaru W
FDA 510(k)
FDA Class 2
·Radiology
VIVIX-M
FDA 510(k)
FDA Class 2
·Radiology
MAMMOMAT B.brilliant
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Genoray Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252229 | BELLIGER ACE | Apr 2, 2026 | Substantially Equivalent |
| K250060 | GT300; GT300-C | Oct 8, 2025 | Substantially Equivalent |
| K232085 | DVAS (DVAS-M, DVAS-W) | Dec 8, 2023 | Substantially Equivalent |
| K232158 | GenX-CR | Sep 13, 2023 | Substantially Equivalent |
| K230787 | Oscar 15 & Oscar 15i | Jul 20, 2023 | Substantially Equivalent |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | May 19, 2022 | Substantially Equivalent |
| K220423 | PAPAYA & PAPAYA Plus | May 19, 2022 | Substantially Equivalent |
| K211780 | ZEN-2090 Turbo | Mar 9, 2022 | Substantially Equivalent |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Sep 16, 2020 | Substantially Equivalent |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Aug 17, 2018 | Substantially Equivalent |