FDA product code · Radiology
IZISystem, X-Ray, Angiographic
Product code IZI covers System, X-Ray, Angiographic, a Class II device regulated under 21 CFR 892.1600. FDA has cleared 199 devices in this code, 3 of them in the last 12 months. Median review time across the 199 most recent decisions is 79 days. openFDA lists 259 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1600
- Review panel
- Radiology
- Clearances
- 199
What is happening in IZI right now?
IZI (System, X-Ray, Angiographic) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2411-2026). 3 first-time filers in the last 12 months, including Stryker Endoscopy and Surgimage Corporation (K261037, K253181, K243645). The code is crowded, scoring 75 of 100 — 84 companies hold a clearance here and 3 arrived in the last 12 months (IZI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2411-2026 |
| New entrant | Worth knowing | K261037, K253181, K243645 |
| Crowding | Context | IZI: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.
How many devices has FDA cleared in IZI?
FDA has cleared 199 devices under product code IZI since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | |
| K243645 | IC-Flow Imaging System 2.0 | Diagnostic Green GmbH | |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | |
| K231986 | Modus IR | Synaptive Medical, Inc. | |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | |
| K214097 | Explorer Air II | Surgvision GmbH |
How long does FDA review take for IZI?
The median FDA review time for IZI is 79 days, measured across the 199 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 IZI?
openFDA lists 259 recall records against product code IZI. A recall record covers one firm's corrective action and may span many device lots.
Z-2411-2026Open, ClassifiedPhilips Medical Systems Nederland B.V.
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Z-0654-2022Open, ClassifiedShimadzu Medical Systems
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
Z-0554-2021Open, ClassifiedShimadzu Medical Systems
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Z-0556-2021Open, ClassifiedShimadzu Medical Systems
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Z-1489-2020TerminatedPhilips North America LLC
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Showing the 5 most recently initiated of 259. 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 IZI?
MAUDE holds 4,685 adverse-event reports naming product code IZI, 1,487 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 IZI unusual?
2 months sit above IZI's own expected range: 1 April 2025, 1 September 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 131 | Insufficient history | No expected range — too little history | |
| 87 | Insufficient history | No expected range — too little history | |
| 166 | Insufficient history | No expected range — too little history | |
| 58 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 73 | Insufficient history | No expected range — too little history | |
| 67 | Insufficient history | No expected range — too little history | |
| 83 | Insufficient history | No expected range — too little history | |
| 190 | Insufficient history | No expected range — too little history | |
| 156 | Insufficient history | No expected range — too little history | |
| 95 | Insufficient history | No expected range — too little history | |
| 78 | Insufficient history | No expected range — too little history | |
| 81 | Insufficient history | No expected range — too little history | |
| 49 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 107 | Insufficient history | No expected range — too little history | |
| 112 | Insufficient history | No expected range — too little history | |
| 128 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 95 | 35–179 | Within expected (35–179) | |
| 88 | 44–135 | Within expected (44–135) | |
| 114 | 62–136 | Within expected (62–136) | |
| 197 | 66–147 | Above expected (66–147) | |
| 156 | 60–191 | Within expected (60–191) | |
| 146 | 65–213 | Within expected (65–213) | |
| 168 | 118–327 | Within expected (118–327) | |
| 165 | 84–229 | Within expected (84–229) | |
| 337 | 93–242 | Above expected (93–242) | |
| 306 | 91–343 | Within expected (91–343) | |
| 245 | 89–350 | Within expected (89–350) | |
| 139 | 102–402 | Within expected (102–402) | |
| 128 | 79–424 | Within expected (79–424) | |
| 102 | 35–328 | Within expected (35–328) | |
| 88 | 8–338 | Within expected (8–338) |
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 IZI.
Who has entered IZI in the last year?
3 companies filed in IZI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Stryker Endoscopy | K261037 | |
| Surgimage Corporation | K253181 | |
| Diagnostic Green GmbH | K243645 |
"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 IZI?
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 IZI?
Across the 199 most recent decisions, these applicants filed most often in IZI.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 13 |
| Xre Corp. | 10 |
| Novadaq Technologies, Inc. | 9 |
| GE Medical Systems | 8 |
| Shimadzu Medical Systems | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in IZI file 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 |
|---|---|---|
| GE Medical Systems, LLC | 10 | 2 |
| Philips Medical Systems North America Inc. | 9 | 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 IZI
Get an email the morning anything changes in IZI — 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.