FDA product code · Radiology
OWBInterventional Fluoroscopic X-Ray System
Product code OWB covers Interventional Fluoroscopic X-Ray System, a Class II device regulated under 21 CFR 892.1650. FDA has cleared 321 devices in this code, 17 of them in the last 12 months. Median review time across the 321 most recent decisions is 89 days. openFDA lists 620 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1650
- Review panel
- Radiology
- Clearances
- 321
What is happening in OWB right now?
OWB (Interventional Fluoroscopic X-Ray System) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2891-2026, Z-2892-2026, Z-2893-2026, Z-2857-2026, Z-2648-2026). 5 first-time filers in the last 12 months, including Pulmera, Inc. and Cara Medical, Ltd (K252735, K252500, K251992, K251893, K251827). Clearances are running 120% slower — a median 196 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days) (OWB:review_time:12m). The code is crowded, scoring 91 of 100 — 107 companies hold a clearance here and 17 arrived in the last 12 months (OWB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2891-2026, Z-2892-2026, Z-2893-2026, Z-2857-2026, Z-2648-2026 |
| New entrant | Worth knowing | K252735, K252500, K251992, K251893, K251827 |
| Review time | Context | OWB:review_time:12m |
| Crowding | Context | OWB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code OWB cover?
OWB is FDA's product code for Interventional Fluoroscopic X-Ray System, a Class II device regulated under 21 CFR 892.1650.
Interventional fluoroscopy
Source: openFDA device/classification · record OWB · retrieved
How many devices has FDA cleared in OWB?
FDA has cleared 321 devices under product code OWB since the 510(k) programme began in 1976, 17 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | |
| K252735 | C-beam | Pulmera, Inc. | |
| K252503 | Intelligent NR | Canon, Inc. | |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | Siemens Medical Solutions USA, Inc. | |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | |
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | |
| K252099 | Trinias | Shimadzu Corporation | |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | |
| K252500 | CARA System | Cara Medical, Ltd. | |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. |
How long does FDA review take for OWB?
The median FDA review time for OWB is 89 days, measured across the 321 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in OWB?
openFDA lists 620 recall records against product code OWB. A recall record covers one firm's corrective action and may span many device lots.
Z-2891-2026Open, ClassifiedPhilips Medical Systems Nederland B.V.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2892-2026Open, ClassifiedPhilips Medical Systems Nederland B.V.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2893-2026Open, ClassifiedPhilips Medical Systems Nederland B.V.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Z-2857-2026Open, ClassifiedOxos Medical, Inc.
Due to a defective circuit board that overheats
Z-2648-2026Open, ClassifiedSiemens Medical Solutions USA, Inc.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Showing the 5 most recently initiated of 620. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for OWB?
MAUDE holds 28,714 adverse-event reports naming product code OWB, 8,971 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in OWB unusual?
4 months sit above OWB's own expected range: 1 February 2025, 1 June 2025, 1 August 2025, 1 September 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 617 | Insufficient history | No expected range — too little history | |
| 452 | Insufficient history | No expected range — too little history | |
| 943 | Insufficient history | No expected range — too little history | |
| 545 | Insufficient history | No expected range — too little history | |
| 820 | Insufficient history | No expected range — too little history | |
| 533 | Insufficient history | No expected range — too little history | |
| 428 | Insufficient history | No expected range — too little history | |
| 518 | Insufficient history | No expected range — too little history | |
| 656 | Insufficient history | No expected range — too little history | |
| 524 | Insufficient history | No expected range — too little history | |
| 862 | Insufficient history | No expected range — too little history | |
| 645 | Insufficient history | No expected range — too little history | |
| 562 | Insufficient history | No expected range — too little history | |
| 627 | Insufficient history | No expected range — too little history | |
| 534 | Insufficient history | No expected range — too little history | |
| 654 | Insufficient history | No expected range — too little history | |
| 698 | Insufficient history | No expected range — too little history | |
| 698 | Insufficient history | No expected range — too little history | |
| 726 | Insufficient history | No expected range — too little history | |
| 729 | Insufficient history | No expected range — too little history | |
| 683 | Insufficient history | No expected range — too little history | |
| 674 | 457–796 | Within expected (457–796) | |
| 851 | 428–697 | Above expected (428–697) | |
| 559 | 508–939 | Within expected (508–939) | |
| 902 | 469–922 | Within expected (469–922) | |
| 836 | 462–959 | Within expected (462–959) | |
| 1,072 | 496–1,054 | Above expected (496–1,054) | |
| 1,066 | 815–1,904 | Within expected (815–1,904) | |
| 1,363 | 566–1,357 | Above expected (566–1,357) | |
| 2,251 | 641–1,637 | Above expected (641–1,637) | |
| 2,227 | 592–2,333 | Within expected (592–2,333) | |
| 1,532 | 569–2,483 | Within expected (569–2,483) | |
| 486 | 627–2,757 | Below expected (627–2,757) | |
| 460 | 242–2,829 | Within expected (242–2,829) | |
| 399 | 0–2,206 | Within expected (0–2,206) | |
| 365 | 0–2,299 | Within expected (0–2,299) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in OWB.
Who has entered OWB in the last year?
5 companies filed in OWB for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Pulmera, Inc. | K252735 | |
| Cara Medical, Ltd. | K252500 | |
| Savfe Co. , Ltd. | K251992 | |
| Skanray Technologies Pvt, Ltd. | K251893 | |
| Philips Medical Systems B.V. | K251827 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in OWB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in OWB?
Across the 321 most recent decisions, these applicants filed most often in OWB.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 37 |
| Philips Medical Systems Nederland B.V. | 28 |
| Ziehm Imaging GmbH | 16 |
| Toshibamedical Systems Corporation | 13 |
| Canon Medical Systems Corporation | 12 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in OWB files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Ziehm Imaging Inc | 21 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch OWB
Get an email the morning anything changes in OWB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.