MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
FDA 510(k) clearance K915766 · decided 1995-07-12
Clearance details
- K-number
- K915766
- Device name
- MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
- Applicant
- J. L. Shepherd and Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-24
- Decision date
- 1995-07-12
- Days to decision
- 1296 days
- Clearance type
- Traditional
- Product code
- MOT
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Fernando, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| RadGil2 (K201177) | R3 X-Ray L.L.C | 2020-08-17 |
| Raycell MK1 (K181737) | Best Theratronics Limited | 2019-01-02 |
| 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 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.