510(k) K201177
- Device
- RadGil2
- Applicant
- R3 X-Ray L.L.C
- 510(k) number
- K201177
- Product code
- MOT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-17
- Date received
- 2020-05-01
- Regulation
- 510(k) Premarket Notification
- Classification name
- Irradiator, Blood To Prevent Graft Versus Host Disease
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Radiology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Robert Hase
- Address
- 2730 E. Broadway Blvd. Suite 160 Tucson AZ US 85716 85716
FDA Registration Numbers#
- 3006946288
- 3002459090
- 3016367050
- 8043725
Source Documents#
Other 510(k) Records For Product Code MOT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181737 | Raycell MK1 | Best Theratronics Limited | 2019-01-02 |
| K172087 | SANGRAY | Hitachi , Ltd. | 2017-10-27 |
| K161324 | Raycell Mk2 | Best Theratronics Limited | 2016-08-12 |
| K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | Rad Source Technologies, Inc. | 2009-02-17 |
| K051065 | RAYCELL X-RAY BLOOD IRRADIATOR | Mds Nordion | 2005-05-26 |
| K050963 | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN | Mds Nordion | 2005-05-20 |
| K032684 | RAYCELL | Mds Nordion | 2003-09-26 |
| K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 | Rad-Source, Inc. | 1998-03-30 |
| K963497 | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 | Nordion International, Inc. | 1996-11-08 |
| K952291 | GAMMACELL 3000 ELAN | Nordion International, Inc. | 1995-08-25 |
| K915766 | MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS | J. L. Shepherd and Assoc. | 1995-07-12 |
| K915767 | MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS | J. L. Shepherd and Assoc. | 1995-07-12 |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Cis-Us, Inc. | 1987-02-26 |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Syncor Intl. Corp. | 1985-09-19 |
| K837346 | MODEL GAMMACELL 1000 | Atomic Energy of Canada | 1983-06-24 |
Legacy Summary#
summary
FDA Review#
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