510(k) K180478
- Device
- RectalPro 75 Endorectal Balloon
- Applicant
- QLRAD International Ltd.
- 510(k) number
- K180478
- Product code
- PCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-13
- Date received
- 2018-02-22
- Regulation
- 892.5720
- Classification name
- Prostate Immobilizer Rectal Balloon
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Arjen Winkel
- Address
- Wormerweg 6 Almere NL 1311 XB 1311 XB
FDA Registration Numbers#
- 1000523114
- 3008513105
- 3014246639
- 3007963782
- 3006948745
- 3040865950
- 3015431711
Source Documents#
Other 510(k) Records For Product Code PCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | 2023-02-10 |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Myriad Medical, LLC | 2015-03-31 |
| K141958 | ERB ENDORECTAL BALLOON | Edge Medical, LLC | 2014-11-18 |
| DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON | Radiadyne | 2014-01-28 |
Legacy Summary#
summary
FDA Review#
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