510(k) K253025
- Device
- Ricoh 3D for Healthcare Bolus
- Applicant
- Ricoh 3D For Healthcare, LLC
- 510(k) number
- K253025
- Product code
- IXI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-06
- Date received
- 2025-09-19
- Regulation
- 892.5710
- Classification name
- Block, Beam-Shaping, Radiation Therapy
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kim Torluemke
- Address
- 5575 Venture Dr. Unit A Parma OH US 44130 44130
FDA Registration Numbers#
- 3022973841
- 3042480122
- 1219183
- 3004073926
- 3032638959
- 3030977776
- 3015232217
- 3006894636
- 3003586672
- 2436865
- 1724955
Source Documents#
Other 510(k) Records For Product Code IXI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022-11-04 |
| K214093 | VSP Bolus | 3D Systems | 2022-03-30 |
| K132236 | .DECIMAL PROTON APERTURE | .Decimal, Inc. | 2013-10-16 |
| K131150 | CURA COMPENSATOR | Cura Medical Technologies, LLC | 2013-07-30 |
| K123893 | CURA COLLIMATOR | Cura Medical Technologies, LLC | 2013-03-04 |
| K123015 | .DECIMAL PHOTON BLOCK | .Decimal, Inc. | 2012-11-21 |
| K111676 | APEX | Elekta Limited | 2011-09-30 |
| K111759 | .DECIMAL ELECTRON APERTURE | .Decimal, Inc. | 2011-09-09 |
| K091403 | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | Oncology Tech, LLC | 2009-07-29 |
| K091911 | BOLUS COMPENSATOR | .Decimal, Inc. | 2009-07-21 |
| K090417 | AXXENT FLEXISHIELD MINI | Xoft, Inc. | 2009-06-23 |
| K071078 | .DECIMAL RANGE COMPENSATOR | .Decimal, Inc. | 2007-05-22 |
| K071077 | .DECIMAL APERTURE | .Decimal, Inc. | 2007-05-18 |
| K062781 | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY | Symtium Corporation | 2006-11-21 |
| K060187 | TOPSLANE DMLC | Topslane International, LLC | 2006-07-27 |