510(k) K113725
- Device
- VIRTUOST
- Applicant
- O.N. DIAGNOSTICS
- 510(k) number
- K113725
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-13
- Date received
- 2011-12-19
- Regulation
- 892.1750
- Classification name
- System, X-ray, Tomography, Computed
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID KOPPERDAHL
- Address
- 2150 Shattuck Ave. Suite 610 Berkeley CA US 94704 94704
FDA Registration Numbers#
- 3008921184
- 3031503890
- 3008496839
- 3010208539
- 9616391
- 3026043045
- 3015276088
- 3003600763
- 3027245002
- 3008632256
- 3039211310
- 3036666444
- 2939827
- 3005496266
- 9616047
- 3010687441
- 3019373577
- 3004977335
- 2183066
- 3010703925
- 3023003446
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025-11-28 |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-10-15 |
| K250662 | Bunkerhill MAC | BunkerHill Health | 2025-10-03 |
Legacy Summary#
summary
FDA Review#
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