Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IXQ — Predicate Candidate Screening

27 FDA 510(k) clearances under this product code; the 50 most recent screened below.

64 daysmedian FDA review time
221 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973842CARBON FIBER CONFORMAL COUCH TOPMedtec, Inc.1997-12-05587
K960083MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300Wuestec Medical, Inc.1996-07-241950
K954225MED-TEC HAND GRIPMedtec, Inc.1995-11-14640
K946262EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLESScott Imaging Intl., Inc.1995-02-15640
K942916OCTOPAQUE UNIVERSALOctostop, Inc.1994-09-08790
K942190ID100 MOBILE FLUOROSCOPIC EXAMINING TABLEImage Diagnostics, Inc.1994-08-171050
K913425DIAL-A-RAD PORTA RAD TABLEDial-A-Rad1992-11-244810
K923775R-MADE HEAD/ARM SUPPORTR-Made, Inc.1992-10-20840
K920729BUCKY TABLE BK-12Shimadzu Medical Systems1992-04-27690
K914351CLINITRON C-10Ssi Medical Services, Inc.1992-02-141400
K912382MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130Continental X-Ray Corp.1991-10-101340
K904187ECONOMY C-ARM TABLE, MODEL # 056-005Atomic Products Corp.1990-11-29780
K904623RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235Atomic Products Corp.1990-11-06260
K903160LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENSContinental X-Ray Corp.1990-08-08210
K893690SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)Hofmann X-Ray of America, Inc.1989-07-20650
K892196RADKOR TS10-BRadkor, Inc.1989-04-26230
K873702REI-38 RADIOGRAPHIC TABLERadiological Engineering, Inc.1988-04-222210
K873849ALTAIREX BUCKY/CASSETTE TRAY COMBINATIONAltairex Manufacturing, Inc.1987-10-28360
K862825HI-LO ELEVATOR FLAT TABLEGarrels X-Ray Products, Inc.1986-09-04410
K862826ITT INTERGRATED TABLE AND TUBESTANDGarrels X-Ray Products, Inc.1986-08-0170
K855052TABLE RADIOGRAPHIC FIXEDX-Ray Systems1986-02-06510
K842094XMC-S TUBESTAND XMT-S TABLE XMH-NTWALLX-Ray Mfg. & Sales, Inc.1985-05-243640
K850118XMA INTEGRATED TABLESummit Industries, Inc.1985-04-09850
K842614CAROLINA X-RAY CO. SIMPLAFLOAT TABLECarolina X-Ray Co., Inc.1984-08-08340
K781681PHIPIOLOGICAL SYNCHRONIZER PART#205Brattle Instrument Corp.1978-10-17150
K781066PLURIX C; RADIOGRAPHIC TABLETecnomed, Inc.1978-07-17210
K781067PLURIX B; RADIOGRAPHIC TABLETecnomed, Inc.1978-07-17210

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda