Atlas FDA

PRECISION 500D R&F X-RAY SYSTEM

FDA 510(k) clearance K081091 · decided 2008-06-11

Clearance details

K-number
K081091
Device name
PRECISION 500D R&F X-RAY SYSTEM
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2008-04-16
Decision date
2008-06-11
Days to decision
56 days
Clearance type
Traditional
Product code
JAA
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch GE Healthcare

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.

RecordFirmDate
Nexus DRF Digital X-ray Imaging System (K253103)Varex Imaging Corporation2026-05-29
Insight Enhancedâ„¢ DRF (EN-1002-01) (K251650)Imaging Engineering, LLC2025-09-16
Soteria E-View (K242488)Omega Medical Imaging, LLC2025-01-06
Adora DRFi (04550010) (K242948)Nrt X-Ray A/S2024-12-23
TRIDENT Mobile Fluoroscopy System (K233380)Dornier Medtech America2024-06-26
ProxiDiagnost N90 / Precision CRF (706110, 706400) (K233945)Philips Medical Systems Dmc GmbH2024-01-11
CombiDiagnost R90 (K232910)Philips Medical Systems Dmc GmbH2023-10-19
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526)Canon Medical Systems Corporation2023-09-12
Nautilus (K220871)Dornier Medtech America, Inc.2022-04-18
Nyquist.IQ (K212890)Omega Medical Imaging, LLC2021-12-13
ProxiDiagnost N90 (K212837)Philips Medical Systems Dmc GmbH2021-09-21
DR 800 with DSA, DR 800 (K212145)Agfa N.V.2021-08-31

Recalls involving this device

RecordFirmDate
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal d recall (Z-1754-2019)GE Healthcare, LLC2019-06-10
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems recall (Z-2179-2017)GE Healthcare, LLC2017-05-22
GE Healthcare Precision 500D Classical R & F system. recall (Z-2120-2015)GE Healthcare2015-07-20
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Sys recall (Z-1966-2015)GE Healthcare2015-07-02
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F recall (Z-0010-2015)GE Healthcare, LLC2014-10-02
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Pre recall (Z-0911-2014)GE Healthcare, LLC2014-02-03
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray recall (Z-0804-2014)GE Healthcare, LLC2014-01-21
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a recall (Z-0012-2014)GE Healthcare, LLC2013-10-17

PMA approvals by this applicant

RecordFirmDate
Senographe Pristina 3D (P130020/S005)GE Healthcare2025-11-21
Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011)GE Healthcare2025-02-04
Senographe Pristina 3D and SenoClaire (P130020/S004)GE Healthcare2021-03-23
Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010)GE Healthcare2018-08-24
Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009)GE Healthcare2018-05-11
Senographe Pristina 3D (P130020/S003)GE Healthcare2017-12-28
Invenia ABUS Autoated Breast Ultrasound System (P110006/S008)GE Healthcare2017-09-07
Invenia ABUS - Automated Breast Ultrasound System (P110006/S007)GE Healthcare2017-05-01