Raycell MK1
FDA 510(k) clearance K181737 · decided 2019-01-02
Clearance details
- K-number
- K181737
- Device name
- Raycell MK1
- Applicant
- Best Theratronics Limited
- Decision
- Substantially Equivalent
- Date received
- 2018-07-02
- Decision date
- 2019-01-02
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- MOT
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Best Theratronics Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RadGil2 (K201177) | R3 X-Ray L.L.C | 2020-08-17 |
| SANGRAY (K172087) | Hitachi , Ltd. | 2017-10-27 |
| Raycell Mk2 (K161324) | Best Theratronics Limited | 2016-08-12 |
| RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (K082921) | Rad Source Technologies, Inc. | 2009-02-17 |
| RAYCELL X-RAY BLOOD IRRADIATOR (K051065) | Mds Nordion | 2005-05-26 |
| GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (K050963) | Mds Nordion | 2005-05-20 |
| RAYCELL (K032684) | Mds Nordion | 2003-09-26 |
| SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (K974210) | Rad-Source, Inc. | 1998-03-30 |
| GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (K963497) | Nordion International, Inc. | 1996-11-08 |
| GAMMACELL 3000 ELAN (K952291) | Nordion International, Inc. | 1995-08-25 |
| MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS (K915766) | J. L. Shepherd and Assoc. | 1995-07-12 |
| MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS (K915767) | J. L. Shepherd and Assoc. | 1995-07-12 |
Recalls involving this device
No recalls on record reference this clearance.